Systems, methods and devices relating to delivery of medical implants

ABSTRACT

Implant delivery systems are disclosed. In general overview, an exemplary system includes any number of the following: a delivery device, a sling assembly, guide members, and connectors that interconnect the above. Embodiments of all the above components and their combinations are disclosed. Methods of using the above system in suprapubic, prepubic, transvaginal, trans-obturator and other approaches are also disclosed.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part application of U.S. patentapplication Ser. Nos. 10/093,371, 10/093,398, 10/093,424, 10/093,450,10/093,498, and 10/094,352 filed in the United States Patent Office onMar. 7, 2002, which claim benefit of and priority to provisional patentapplication Ser. No. 60/274,843 filed in the United States Patent Officeon Mar. 9, 2001 and provisional patent application Ser. No. 60/286,863filed in the United States Patent Office on Apr. 26, 2001. The entirecontents of these six nonprovisional applications are incorporated byreference herein. This application is also based on and claims priorityto certain provisional U.S. patent applications, namely, Ser. No.60/403,555 filed on Aug. 14, 2002, Ser. No. 60/418,827 filed on Oct. 15,2002, Ser. No. 60/418,642, filed on Oct. 15, 2002, Ser. No. 60/434,167filed on Dec. 17, 2002, Ser. No. 60/449,465 filed on Feb. 24, 2003, Ser.No. 60/465,722 filed on Apr. 25, 2003, and Ser. No. 60/483,534 filed onJun. 27, 2003, the entire contents of all of which are incorporatedherein by reference.

TECHNICAL FIELD

The invention relates generally to systems, methods and devices fordelivering a medical implant, to an anatomical site in the body of apatient.

BACKGROUND OF THE INVENTION

Urinary incontinence occurs in both men and women. Various types ofincontinence are caused by different conditions and call for differenttreatments. For example, stress urinary incontinence (SUI) is known tobe caused by at least two conditions, intrinsic sphincter deficiency(ISD) and hypermobility. In women, these conditions may occurindependently or in combination. In ISD, the urinary sphincter valve,located within the urethra, fails to close properly (coapt), causingurine to leak out of the urethra during stressful activity.Hypermobility is a condition in which the pelvis floor is distended,weakened or damaged, causing the bladder neck and proximal urethra torotate and descend in response to increases in intra-abdominal pressure(for example, due to sneezing, coughing, straining, etc.). As a result,the patient's response time becomes insufficient to promote urethralclosure and, consequently, the patient suffers from urine leakage and/orflow.

One way to treat incontinence, both in men and women, is to place asurgical sling or suture in the periurethral tissue such as under thebladder neck or the urethra to provide a urethral platform. Placement ofthe sling limits the endopelvis fascia drop while providing compressionto the urethral sphincter to improve coaptation. The sling may beaffixed using a bone anchoring method. Alternatively, a medicalprofessional can use an anchorless approach to stabilize the urethrawith a sling by placing the sling in the periurethral tissue and relyingon tissue compression and eventual tissue in-growth to secure the slingin position.

SUMMARY OF THE INVENTION

The invention addresses deficiencies of the prior art by providingdevices, systems and methods for facilitating delivery of an implant toan anatomical site. According to a preferred embodiment, the device canbe used to deliver an implant, such as a sling for treating urinaryincontinence, to a mid-urethral location of a patient. The methods andsystems of the invention simplify the delivery of the implant by using aconnector pair for attaching a medical implant to a delivery device.

The invention includes connector pairs having various configurations.For example, the medical implant can include a closed loop or receptacleconnector which interfits with a plug connector at the distal end of adelivery system component such as a shaft or elongated tube. The loop orreceptacle connector and the plug connector can be so configured thatthey snap fit together, be threaded together or the receptacle connectorcan include axial projections having a protrusion that interlock withthe plug connector. As in all of the embodiments described herein, thelocation of the connectors of a particular connector pair may beswapped, for example, so that the plug connector may be located at anend of the medical implant and the loop connector may be located at thedistal end of delivery system component. Additionally, the deliverycomponent connector need not be at its distal end, but instead may belocated anywhere along it.

In another example, a receptacle connector is located at the end of theimplant and includes a base section for receiving the plug connector.The receptacle connector can have an outer annular collar forconcentrically sliding over the base section to compress the base andlock the plug connector in the receptacle connector or a laterallyopening access cover for receiving the plug connector and when closedlocks the plug connector into the receptacle connector. In anotherexample, the receptacle connector can include a housing having asubstantially tubular wall which can include a plurality of longitudinalexpansion slots, an axially extending slot through the wall or anaperture in the wall into which a plug connector is inserted. Oneadvantage of the invention is that it provides connector pairs foreffective and simple connection between an implant and a delivery systemcomponent.

The connector pairs described below can all be used for attaching amedical implant such as a sling assembly to the distal end of a deliverysystem or delivery system component. The connector pair includes a loopor receptacle connector located at an end of the medical implant and aplug connector located at the distal end of a delivery device componentsuch as a shaft or an elongated tube.

In one aspect, the connector pair includes a closed loop connectorformed from a filament and a plug connector for interfitting with theclosed loop connector of the medical implant, the plug connectorincluding an intermediate section having a diameter less than that ofthe distal end of the shaft and extending distally from the distal endof the shaft, and a conical tip section, with a base located adjacent tothe intermediate section and having a diameter larger than the diameterof the intermediate section, extending distally from the intermediatesection.

In one embodiment, the closed loop connector includes a helical loopformed in the filament, and sized to receive the conical tip of the plugconnector and snap fit into the intermediate section of the plugconnector. The helical loop can be formed to expand over the conical tipof the plug connector and contract into the intermediate section of theplug connector. The conical tip can mate with the helical loop fromoutside a perimeter described by the closed loop connector to, forexample, connect the medical implant and the shaft in an end-to-endconfiguration.

The closed loop connector can include a first section having asubstantially triangular shape. In one embodiment, the first sectionaxially extends from a base at the end of the medical implant to anapex, and neck section having a width substantially equal to the widthof the apex and extending axially from the apex to the helical loop, thehelical loop having a diameter larger than the width of the necksection. In another embodiment, the first section is substantiallylocated in a first plane and axially extends from a base width at theend of the medical implant to a narrowed width at an apex, and a secondsection, having a substantially U-shape and the narrowed width, andextending from the apex in a second plane angled from the first plane.The U-shaped section can have an angle of curvature, for example, ofgreater than about 270 degrees, about 90 degrees and about 45 degrees.The narrowed width can be substantially equal to the diameter of theintermediate section of the plug connector or less than that thediameter of the base of the conical tip.

The intermediate section of the plug connector can interfit with theU-shaped second section of the closed loop connector so that wheninterfitted, the conical tip is substantially inside or outside aperimeter described by the closed loop connector, thereby connecting themedical implant and the shaft in an end-to-end configuration. In oneembodiment, the closed loop connector includes a neck section having awidth substantially equal to the narrowed width at the apex of the firstsection and extending axially from the apex to the substantiallyU-shaped second section. The substantially U-shaped second sectionpreferably has a width of less than the diameter of the base of theconical tip.

In another aspect, the connector pair includes a receptacle connectorhaving a laterally extending aperture with an aperture diameter, a plugconnector for interfitting with the laterally extending aperture of thereceptacle connector, the plug connector including a first sectionhaving a diameter less than or equal to the aperture diameter, and asecond section axially extending in a distal direction from the firstsection and having a diameter greater than the aperture diameter that ofthe distal end of the delivery system component.

In one embodiment, the second section of the plug connector is forcedthrough the laterally extending aperture of the receptacle connector sothat the first section extends through the laterally extending aperture.The second section of the plug connector can have various configurationsincluding a conical tip having a base adjacent to the first section ofthe plug connector, a bulbous portion or a spearhead shaped portion. Thereceptacle connector can include an axially extending and elongatedsubstrate having a terminal end through which the laterally extendingaperture is formed.

In another aspect, the connector pair includes a receptacle connectorincluding a receptacle having first and second ends and a lumenextending there between, and an elongated tongue section for spacing thereceptacle axially away from the sling assembly, a plug connector andcompressible to axially snap fitting into the receptacle connector. Theplug connector can snap fit into the receptacle via the first end or viathe second end.

In another configuration, the connector pair includes a receptacleconnector including a substantially cylindrical base and a plurality ofaxial projections located radially around the substantially cylindricalbase and defining an expandable channel, a plug connector and shaped forinterfitting with the expandable channel of the receptacle connector.The expandable channel can have an initial diameter prior to expansionsized to matingly seat the delivery system component such a shaft orelongate tube.

In one embodiment, each of the axial projections include a protrusionextending radially into the expandable channel and the plug connectorincludes an intermediate section having a diameter less than the distalend of the delivery system component for engaging the radially extendingprotrusions to interlock the plug and receptacle connectors.Alternatively, each of the axial projections include a protrusionextending radially outward from the plug connector to form an expandedconical head.

In another embodiment, the plug connector includes an end section, forexample, which is conical shaped, extending distally from theintermediate section, and having a base with a diameter larger than thediameter of the intermediate section, the base being located adjacent tothe intermediate section.

In another configuration, the connector pair includes a plug connectorand a receptacle connector including a base section for receiving theplug connector and an outer annular collar for concentrically slidingover the base section to compress the base section and lock the plugconnector in the receptacle connector. The plug connector can include anintermediate section having a diameter less than that of the distal endof the delivery system component and extending distally from the distalend of the delivery system component, and a tip section, extendingdistally from the intermediate section, and having a base with adiameter larger than the diameter of the intermediate section, the basebeing located adjacent to the intermediate section, and the base sectionof the receptacle connector includes a radially inwardly protrudingcollar for interfitting with the intermediate section of the plugconnector in response to the outer annular collar compressing the basesection.

In another aspect, the invention features a connector pair including aplug connector and a receptacle connector including a base for receivingthe plug connector and a laterally opening access cover, the accesscover being opened to seat the plug connector in the base and closed tolock the plug connector into the receptacle connector. The plugconnector can include at least one reduced diameter section, and atleast one of the base and the laterally opening cover of the receptacleconnector includes at least one protrusion to interfit with the at leastone reduced diameter section of the plug connector.

In another configuration, invention features a connector pair includinga plug connector and a receptacle connector including a housing having asubstantially tubular wall, the substantially tubular wall including aplurality of longitudinal expansion slots, the receptacle connectorfurther including at least one radial projection extending radiallyinward from the substantially tubular wall, the at least one radialprojection being deflectable in response to insertion of the plugconnector into the receptacle connector. The plug connector can includeat least one reduced diameter section for the radial projection toextend into in response to the plug connector being fully seated intothe receptacle connector. The at least one radial projection can bespring loaded and deflects radially outward from the substantiallytubular wall during insertion of the plug connector into the receptacleconnector or includes a flap that deflects radially during insertion ofthe plug connector into the receptacle connector.

The connector pair can also be configured to include a plug connectorwith an intermediate section having a diameter less than that of thedistal end and extending distally from the distal end of the deliverysystem component, and a tip section, extending distally from theintermediate section, and having a base with a diameter larger than thediameter of the intermediate section, the base being located adjacent tothe intermediate section, and a receptacle connector located at an endof a medical implant and including a housing having a substantiallytubular wall extending between first and second ends of the housing, thesubstantially tubular wall including an axially extending slot throughthe wall, the axially extending slot being sized to interfit with theintermediate portion of the plug connector.

According to one feature, the axially extending slot extends from thefirst end to the second end of the housing and optionally includes aradially enlarged portion sized to accommodate the tip section of theplug connector.

In another configuration, a connector pair includes a plug connectorlocated at distal end of a delivery system component, and including anintermediate section having a diameter less than that of the distal endof the delivery system component and extending distally from the distalend of the delivery system component, and a tip section, extendingdistally from the intermediate section, and having a base with adiameter larger than the diameter of the intermediate section. The basecan be located adjacent to the intermediate section. The connector pairalso includes a receptacle connector having a housing with first andsecond ends, the first end located at an end of a medical implant, andincluding an aperture extending radially through the housing from afirst side to a second side, a first channel extending along the firstside of the housing from the aperture to the first end, and a secondchannel extending along the second side from the aperture to the secondend. The tip section can be passed through the aperture from the firstside to the second side and the plug and receptacle connectors arerotated relative to each other to seat the intermediate section in thefirst and second channels.

In another aspect, the invention features a connector pair including athreaded plug connector located at distal end of a delivery systemcomponent, and a threaded receptacle connector, located at an end of amedical implant, for threaded engagement with the threaded plugconnector.

In another configuration, the invention features a connector pairincluding a plug connector and a receptacle connector including at leastone adhesive surface for bonding to at least one of the plug connectorand the delivery system component subsequent to mating. The adhesivesurface can include adhesive flaps diametrically opposed to each otherfor adhering to opposite sides of at least one of the plug connector andthe delivery system component. In one embodiment, the protectivecovering protect the adhesive surface until bonding.

In another embodiment, the invention features a connector pair includinga receptacle connector including a substantially tubular housing havingfirst and second ends, a wall extending there between, and a throughaperture formed in the wall intermediate to the first and second ends, aspring member located adjacent to an outside portion of the housing walland having a protuberance at a first end for projecting through theaperture in the housing wall, and a plug connector having a reduceddiameter section for engaging with the protuberance at the first end ofthe spring through the through aperture in the housing wall duringinsertion into the receptacle connector. The tubular collar can beconcentrically interfitted around the receptacle connector for slidingover the spring member to cause the protuberance to engage with thereduced diameter section of the plug connector.

In another aspect, the connector pair includes a plug connectorincluding an axially extending slot having a keying feature, and areceptacle connector including at least one projection for mating withthe keying feature on the plug connector in response to inserting theplug connector into the receptacle connector and rotating the plug andreceptacle relative to each other.

In still yet another configuration, the connector pair includes an openloop connector formed from a filament including first and second hookedends crossed relative to each other, and a plug connector includingfirst and second notches for interfitting with the first and secondhooked ends respectively.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, like reference characters generally refer to the sameparts throughout the different views. The drawings are not necessarilyto scale and emphasis instead is generally placed upon illustrating theprinciples of the invention.

FIG. 1 depicts a perspective side view of a delivery device including ahandle and needle according to an illustrative embodiment of theinvention.

FIG. 2 depicts an enlarged perspective side view of the handle and aportion of the needle of the device of FIG. 1.

FIG. 3 depicts a perspective side view of the delivery device of FIG. 1with a pusher assembly incorporated into the device according to anillustrative embodiment of the invention.

FIG. 4 depicts a perspective side view of the pusher assembly shown inFIG. 3.

FIG. 5 depicts an enlarged perspective side view of the handle andpusher assembly portion of the device shown in FIG. 3.

FIG. 6 depicts a longitudinal cross-sectional view of a pusher assemblyon a delivery device according to an alternative embodiment of theinvention.

FIG. 7A depicts a perspective side view of a delivery device thatincludes a guide tube and a shaft, with the guide tube actuated to be ina first position relative to the shaft according to an embodiment of theinvention.

FIG. 7B depicts a perspective side view of the delivery device of FIG.7A where the guide tube is actuated to be a second position relative tothe shaft.

FIG. 8A depicts a perspective side view of a delivery device thatincludes a guide tube and a shaft, with the shaft actuated to be in afirst position relative to the guide tube, according to an alternativeembodiment of the invention.

FIG. 8B depicts a perspective side view of the delivery device of FIG.8A with the shaft actuated to be in a second position relative to theguide tube.

FIG. 9A depicts a perspective side view of a delivery device accordingto another illustrative embodiment of the invention.

FIG. 9B depicts a cross-sectional view of the device shown in FIG. 9Aalong the line “9B-9B.”

FIG. 10A depicts a perspective side view of an exemplary guide tubeaccording to one illustrative embodiment of the invention.

FIG. 10B depicts a side view of a portion of the guide tube of FIG. 10Aaccording to an illustrative embodiment of the invention.

FIG. 11 depicts a side view of an alternative illustrative embodiment ofa portion of a guide tube of the general type depicted in FIG. 10A.

FIG. 12 depicts a perspective side view of a portion of a deliverydevice including a handle and a shaft according to another illustrativeembodiment of the invention.

FIGS. 13A and 13B depict perspective side views of delivery devices withmultiple bends according to illustrative embodiments of the invention.

FIGS. 14-16 depict perspective side views of illustrative deliverydevices, each having a variously angled distal end according to theinvention.

FIG. 17 depicts a perspective side view of a particularly curveddelivery device according to an illustrative embodiment of theinvention.

FIG. 18 depicts a perspective side view of alternatively curved deliverydevices according to another illustrative embodiment of the invention.

FIG. 19 depicts a top view of an exemplary sling assembly that may beemployed with the various illustrative delivery devices of theinvention.

FIG. 20 depicts a top view of another exemplary sling assembly that maybe employed with the various illustrative delivery devices of theinvention.

FIG. 21 depicts a top view of another exemplary sling assembly that maybe employed with the various illustrative delivery devices of theinvention.

FIG. 22A depicts a side perspective view of a loop connector and matingreceptacle connector prior to interconnection, according to anillustrative embodiment of the invention.

FIG. 22B depicts a top view of the connectors of FIG. 22A, with aninterconnected state shown in phantom.

FIG. 22C depicts a side view of the connectors of FIG. 22A partiallyinterconnected according to an illustrative embodiment of the invention.

FIG. 22D depicts a side view of the connectors of FIG. 22A fullyinterconnected.

FIG. 23 depicts a perspective top view of interconnected loop andreceptacle connectors according to another illustrative embodiment ofthe invention.

FIG. 24 depicts a perspective side view of a receptacle connector of thetype that may be employed with the loop connector of FIG. 23.

FIG. 25 depicts a perspective side view of a receptacle connector and amating loop connector according to an illustrative embodiment of theinvention.

FIG. 26 depicts a cross-sectional side view of an alternative receptacleconnector of the type that may be employed with the loop connectors ofFIGS. 23 and 25.

FIGS. 27-31 depict side views of various additional receptacleconnectors of the type that may be employed with the loop connectors ofFIGS. 23 and 25, according to various embodiments of the invention.

FIG. 32A depicts a side view of another receptacle connector of the typethat may be employed with the loop connectors of FIGS. 23 and 25.

FIG. 32B depicts a side perspective view of the receptacle connector ofFIG. 32A.

FIG. 33 depicts a side perspective view of a loop and mating receptacleconnector pair according to another illustrative embodiment of theinvention.

FIG. 34 depicts a side perspective view of an alternative embodiment ofthe loop connector of FIG. 33.

FIG. 35A depicts a side perspective view of a connector pair prior tointerconnection.

FIG. 35B depicts a side perspective view of the connector pair of FIG.35A subsequent to interconnection.

FIG. 36A depicts a side perspective view of a loop connector with anadjustable loop according to an embodiment of the invention.

FIG. 36B depicts a cross-sectional view, along the line “36B-36B,” ofthe loop connector shown in FIG. 36A.

FIG. 37A depicts a side perspective view of the loop connector of FIG.36A interconnected with a mating receptacle connector with the loopconnector in an extended state.

FIG. 37B depicts a side perspective view of the connector pair of FIG.37A with the loop connector in a retracted state.

FIG. 38 depicts a cross-sectional view of an adjustable loop connectoraccording to another illustrative embodiment of the invention.

FIG. 39A depicts a top perspective view of a plug and receptacleconnector pair according to an illustrative embodiment of the invention.

FIG. 39B depicts a top perspective view of the connector pair of FIG.39A interconnected in an in-line configuration.

FIG. 39C depicts a top perspective view of the connector pair of FIG.39A interconnected in an alternative configuration.

FIG. 40A depicts a top perspective view of a plug and loop connectorpair according to another illustrative embodiment of the invention.

FIG. 40B depicts an enlarged top view of a portion of the loop connectorof FIG. 40A.

FIG. 41A depicts a top perspective view of the plug connector of FIG.40A and an alternative configuration of the loop connector of FIG. 40A.

FIG. 41B depicts a perspective side view of the connector pair of FIG.41A in an interconnected state with an in-line configuration.

FIG. 41C depicts a perspective side view of the connector pair of FIG.41A in an interconnected state with an alternative configuration.

FIG. 42A depicts a side perspective view of a plug and receptacleconnector pair along with components of an implant delivery systemincluding a shaft, a guide tube and a sling assembly, according toanother illustrative embodiment of the invention.

FIG. 42B depicts a side perspective view of an alternative embodiment tothe plug and receptacle connector pair of FIG. 42A.

FIGS. 43 and 44 depict side views of alternative embodiments of plugconnectors of the type depicted in FIGS. 42A and 42B.

FIG. 45 depicts a side perspective view of a plug and receptacleconnector pair where the plug connector alternately contracts andexpands to interlock with the receptacle connector, and a release tool,according to an illustrative embodiment of the invention.

FIG. 46A depicts a side perspective view of a plug and receptacleconnector pair where the receptacle connector alternately expands andcontracts to interlock with the plug connector.

FIG. 46B depicts a cross-sectional end view of the distal end of thereceptacle connector shown in FIG. 46A, along the line “46B-46B.”

FIGS. 46C and 46D depict longitudinal cross-sectional views ofalternative embodiments of the receptacle connector shown in FIG. 46Aalong the line “46C/46D-46C/46D.”

FIGS. 47 and 48 depict longitudinal cross-sectional views of receptacleand plug connector pairs at different stage of interconnection accordingto an illustrative embodiment of the invention.

FIG. 49A depicts an exploded view in perspective of a portion of a plugand receptacle connector pair according to another illustrativeembodiment of the invention.

FIG. 49B depicts a cross-sectional view of a portion of the receptacleconnector of FIG. 49A, along the line “49B-49B.”

FIG. 50A depicts a side perspective view of a plug and receptacleconnector pair where the receptacle opens and closes to facilitateinterconnection, according to an illustrative embodiment of theinvention.

FIG. 50B depicts a side perspective view of an alternative embodiment ofthe connector pair of FIG. 50A.

FIG. 51A depicts a side perspective view of a plug and receptacleconnector pair with a protuberance to facilitate interlocking, accordingto an embodiment of the invention.

FIG. 51B depicts a cross-sectional view of the receptacle connector ofFIG. 51A along the line “51B-51B.”

FIG. 52 depicts a side view partially in perspective of a receptacleconnector similar to the receptacle connector of FIG. 51A, but includinga flap, according to an illustrative embodiment of the invention.

FIG. 53 depicts a side perspective view of a receptacle and plugconnector pair, according to another illustrative embodiment of theinvention.

FIG. 54A depicts a side perspective view of a receptacle connector,according to another illustrative embodiment of the invention.

FIG. 54B depicts a cross-sectional view of the connector of FIG. 54A,along the line “54B-54B.”

FIG. 54C depicts a side perspective view of the receptacle connector ofFIG. 54A partially interconnected with the type of plug connectordepicted in FIG. 53.

FIG. 55 depicts a top schematic view of a connector pair as analternative embodiment to the connector pair of FIG. 54C.

FIG. 56A is a perspective top view illustrating interconnection betweena receptacle and plug connector pair, according to an embodiment of theinvention.

FIGS. 56B-56D depict cross-sectional views of the receptacle connectorof FIG. 56B, at various locations along its length.

FIG. 57 depicts a perspective side view in partial cross-section of athreadable receptacle and plug connector pair.

FIG. 58A depicts a side view perspective of a plug and receptacleconnector pair in which the receptacle and plug connectors adhere toeach other during interconnection.

FIG. 58B depicts a perspective side view of the connector pair of FIG.58A subsequent to interconnection.

FIG. 59A depicts a perspective side view of a plug and receptacleconnector pair that employs a spring-loaded locking device forinterconnection, according to another illustrative embodiment of theinvention.

FIG. 59B depicts a perspective side view of the connector pair of FIG.59A subsequent to interconnection.

FIG. 60 depicts a side view in partial cross-section of a plug andreceptacle connector pair, according to another illustrative embodimentof the invention.

FIG. 61A depicts a longitudinal cross-sectional view of a receptacleconnector, and a side view of its mating plug connector, according toanother illustrative embodiment of the invention.

FIG. 61B depicts a longitudinal cross-sectional view of the connectorpair of FIG. 61A.

FIG. 62 depicts a perspective side view partially in cross-section of aconnector pair, according to another illustrative embodiment of theinvention.

FIG. 63A depicts a delivery system that includes a handle, a shaft, aguide tube, a sling assembly and connectors according to an illustrativeembodiment of the invention.

FIG. 63B depicts a radial cross-sectional view of the guide tube of FIG.63A along the line “63B-638.”

FIG. 63C depicts a longitudinal cross-sectional view of the plugconnector of FIG. 63A along the line “63C-63C.”

FIG. 63D depicts a longitudinal cross-sectional view of the receptacleconnector of FIG. 63A along the line “63D-63D.”

FIG. 64 depicts a longitudinal cross-sectional view of theinterconnection between the shaft, receptacle and plug connectors ofFIG. 63A.

FIG. 65A depicts a perspective side view of a delivery device includinga sheath at an advanced position, according to an illustrativeembodiment of the invention.

FIG. 65B depicts a perspective side view of a delivery device of thetype depicted in FIG. 65A interconnected with a sleeve end through aloop connector and a slotted receptacle connector, where the sheath isin a retracted position.

FIG. 66A depicts a perspective side view of interconnection between thedelivery device and the sleeve end depicted in FIG. 65B with analternative embodiment of the sheath.

FIG. 66B depicts a partial cross-sectional view of the interconnectionbetween a receptacle connector and a loop connector with a lockingsheath embodiment.

FIG. 67A depicts a side perspective view of an L-shaped receptacleconnector and a mating loop connector, with a sheath located to enableinterconnection according to an illustrative embodiment of theinvention.

FIG. 67B depicts a side perspective view of the connector pair of FIG.67A with the loop and L-shaped receptacle interfitted and the sheathlocated to facilitate locking.

FIG. 68 depicts a cross-sectional view of a delivery device including aguide tube having connectors for mounting a sling assembly shown inperspective, according to an illustrative embodiment of the invention.

FIG. 69 depicts a perspective side view of the components shown in FIG.68 assembled together, according to an illustrative embodiment of theinvention.

FIG. 70 depicts a perspective side view of an assembled delivery systemwith two guide tubes, a shaft with a handle, a sling assembly, andconnectors, according to another illustrative embodiment of theinvention.

FIG. 71 depicts a perspective side view of an assembled delivery systemwith two guide tubes that are alternative embodiments of the ones shownin FIG. 70, a shaft with a handle, a sling assembly, and connectors,according to another illustrative embodiment of the invention.

FIG. 72 depicts a perspective side view of an assembled delivery systemwith two ends of a sling assembly attached to two guide tubes where eachguide tube slidably fits over a handled shaft next to a pusher assembly,according to one embodiment of the invention.

FIG. 73A depicts a schematic view of the tunneling step, using anoptional guide tube, in a suprapubic approach to delivering a sling toan anatomical site, according to illustrative embodiments of theinvention.

FIG. 73B depicts a schematic view of interconnection and other stepswithout using a guide tube subsequent to the step shown in FIG. 73A.

FIG. 73C depicts a schematic view of interconnection and other stepsusing guide tubes subsequent to the step shown in FIG. 73A.

FIG. 73D depicts a schematic view of steps subsequent to those shown ineither FIG. 73B or 73C.

FIG. 73E depicts a schematic view of the final placement of a sling totreat urinary incontinence.

FIG. 74 depicts a schematic view of a suprapubic delivery approach usingthe shaft of the type shown in FIG. 14 where one previous position ofthe delivery device is shown in phantom, according to an illustrativeembodiment of the invention.

FIG. 75 depicts a schematic view of a prepubic delivery approach usingthe delivery device of FIG. 74 where one previous position of thedelivery device is shown in phantom, according to an illustrativeembodiment of the invention.

FIGS. 76A and 76B depict schematic views of steps in a transvaginalapproach where a medical implant is interconnected to a distal end of ashaft for delivery to an anatomical site in the patient.

FIG. 77 depicts a schematic view of steps in a transvaginal approachwhere the implant is interconnected to a distal end of a guide tube fordelivery to an anatomical site in the patient.

FIGS. 78A and 78B depict schematic views of steps in a transvaginalapproach where the implant is interconnected to a proximal end of aguide tube for delivery to an anatomical site in the patient.

FIGS. 79A and 79B depict schematic views of steps in a transvaginalapproach where the implant is interconnected to both distal and proximalends of a guide tube for delivery to an anatomical site in the patient.

FIGS. 80A and 80B depict schematic views of steps in a transvaginalapproach where the implant is interconnected to two guide tubessimultaneously for delivery to an anatomical site in the patient.

FIGS. 81A and 81B depict schematic views of steps in a trans-obturatorapproach to deliver a medical implant to an anatomical site in thepatient, according to another illustrative embodiments of the invention.

FIG. 82 depicts a side perspective view of a sling assembly with twomale guide members, and a delivery device, according to an illustrativeembodiment of the invention.

FIG. 83 depicts a side perspective view of an alternative embodiment tothe male guide members of FIG. 82, according to an embodiment of theinvention.

FIG. 84A depicts a schematic view of steps in a suprapubic or prepubicdelivery approach using a delivery device including a shaft and a guidetube.

FIG. 84B depicts a schematic view of steps in a transvaginal deliveryapproach using the delivery device shown in FIG. 84A.

FIG. 84C depicts a schematic view of steps using the male guide membersof the general type shown in FIG. 82 subsequent to steps shown in FIG.84A or 84B.

FIG. 85 depicts a side perspective view of an implant delivery systemincluding two female guide members, according to an illustrativeembodiment of the invention.

FIGS. 86A and 86B depict schematic views of steps in a suprapubic orprepubic delivery approach using the delivery device of FIG. 85.

FIGS. 87A and 87B depict schematic views of steps in a transvaginaldelivery approach using the delivery device of FIG. 85.

DESCRIPTION

The invention relates to delivering and placing an implant, such as asling, mesh, or suture, for the treatment of urinary incontinence, at ananatomical site (such as the periurethral tissue) in the body of amammal. The patient may be either a female patient or a male patient.

The following description is divided into five sections. The firstsection, describes various illustrative delivery devices. The secondsection describes implants (such as sling assemblies) that may bedelivered by, without limitation, any of the illustrative deliverydevices. The third section describes connectors that may be used tointerconnect two or more parts in an implant delivery system, such as,for example, interconnecting a sling assembly with a delivery device.The fourth section describes various illustrative methods for treatmentof urinary incontinence, including illustrative embodiments that utilizecomponents and systems described in this and the incorporated patentsand patent applications. The fifth section describes guide members thatmay be interconnected with the sling assembly and their related methodsof use. A delivery device, an implant, and optionally one or more guidemembers and/or connectors together generally form an implant deliverysystem.

It should be noted that, any of the described components (in anydescribed variations) can be operatively combined with one or more ofany of the other described components (in any described variations), andsuch operative combinations are intended to fall within the scope of theinvention and are included herein even if not expressly called out.

I. Delivery Devices

Without limitation, exemplary delivery systems, slings, slingattachments and methodologies that may be employed in combination withthe spacers of the invention can be found in U.S. patent applicationSer. No. 10/093,498; U.S. patent application Ser. No. 10/093,398; U.S.patent application Ser. No. 10/093,450; U.S. patent application Ser. No.10/094,371; U.S. patent application Ser. No. 10/094,352; U.S. patentapplication Ser. No. 10/093,424; U.S. provisional patent applicationSer. No. 60/403,555; U.S. patent application Ser. No. 09/916,983; U.S.provisional patent application Ser. No. 60/465,722; U.S. provisionalpatent application Ser. No. 60/418,827; U.S. provisional patentapplication Ser. No. 60/418,642; U.S. provisional patent applicationSer. No. 60/274,843; U.S. provisional patent application Ser. No.60/286,863; and U.S. provisional patent application Ser. No. 60/434,167,the disclosures of which are incorporated herein by reference.

Referring to FIG. 1, an illustrative delivery device 10 includes ahandle 12 associated with a curved shaft 14. The shaft 14 may be, forexample, any suitable needle, cannula, tubular member, tunneler, dilatoror the like. The delivery device 10 may also include other components,such as connectors, sheaths, guide tubes and actuating assemblies,described in further detail below. A distal end 24 of the curved shaft14 is marked by circle “A” to indicate that it may include one or moreconnectors such as the ones described below.

In one illustrative embodiment, the curved shaft 14 is formed from arigid material, for example, a metal or a polymeric material. Examplesof suitable metals include, but are not limited to, stainless steel,titanium, and alloys such as nitinol. Suitable polymers, which can beused as a coating on a metal to form the shaft 14, include but are notlimited to, plastics such as polytetrafluoroethylene (PTFE). In oneembodiment, the shaft 14 is rigid. In another embodiment, the shaft 14has some flexibility, and can be described as semi-rigid. The shaft 14has a proximal end 22, i.e., the end that is closest to an origin ofattachment, typically the operator, and the distal end 24. The shaft 14generally has a pointed tip 26 at the distal end 24 that is designed forpercutaneous punctuation and/or advances through the tissue. However,the tip 26 may be blunt or sharp. In some configurations, the tip 26 isconical. A blunt tip 26 may provide some resistance to unintendedpenetration through tissue or organ, such as the bladder. The distal end24 of the shaft 14 may include a tapered section 28 that leads to thedistal tip 26. The tapered section 28 aids dilation and tunnelingthrough the tissue.

The shaft 14 may be solid or hollow. If the shaft 14 is at least partlyhollow, it may include a lumen (not shown) that has one or more openingson the shaft 14, for example, at the distal tip 26 or along the side ofthe shaft 14. The cross-section of the shaft 14 may have a constantshape and size, or its shape and size may vary along the length of theshaft 14. The cross-section of the shaft 14 may assume any shape, forexample, circular, semi-circular, oval, triangular or rectangular. Inother embodiments, the distal end 24 may include an enlarged, flaredportion to dilate tissue beyond the typical diameter of the shaft 14.

Part or the entire shaft 14 may assume a curved, angled, a helical shapeor any other suitable shape including substantially straight. Differentshapes of the shaft 14 have advantages in different procedures, which isdiscussed in more detail below.

In one embodiment, the surface of the shaft 14 is smooth. However, thesurface of the shaft 14 may be coated with one or more drugs such asanesthetic, anti-inflammatory, coagulating, anticoagulating, antibioticor antimicrobial agents. The drug may be delivered to the patient'stissue while the shaft 14 is in contact with the tissue. The surface ofthe shaft 14 may be coated with a light-absorbing coating to reduceglare, for example, under a cystoscope. The coating may be a polymer,such as Teflon, or other suitable material, and may be colored to aid indetection. The surface of the shaft 14 may be painted so that one caneasily tell it apart from surrounding tissue and fluid under acystoscope to make it easier to detect under the cystoscope. In otherillustrative embodiments, the shaft 14 is textured, for example, bystippling, to provide increased traction relative to a gloved hand of amedical operator. In another illustrative embodiment, the shaft 14 isfitted with a colored sheath, such as a blue plastic sheath or guidetube.

The handle disposed at the proximal end of the device for the variousdevices illustrated herein is depicted with particular configurations,but may be manufactured from rigid or flexible plastic, or a combinationthereof, and may assume any suitable shape (such as a substantiallycylindrical or T-shape) to fit a particular application with which it isused, for example, such applications described in detail below.Advantageously, the handle is of an ergonomic design and constructionthat reduces operator fatigue and discomfort, provides needed leverageand gripping surface for the user, orients the user as to the directionof the needle, and/or provides fingertip or palm control over theneedle. For example, in FIG. 2, the handle 12 is substantially D-shapedor kidney-shaped, and has a proximal end 15, a distal end 16, a firstface 18, and a second, opposite face 19 (shown in FIGS. 1 and 3). Theproximal end 15 of the handle 12 is relatively flat with a slight curve,and rests comfortably against the operator's palm. The operator'sfingers stabilize the distal end 16 of the handle 12 by gripping the twocutoff sections 20 a and 20 b that flank the distal end 16. The handle12 may also include external ribs 21 a and 21 b on one or both sides ofthe handle 12. The external ribs 21 a, 21 b provide tactile orientationof the handle 12 for the operator. Optionally, the handle 12 includesribs or grooves 17 on one or both faces 18 and 19 of the handle 12,which may also assist gripping and inhibit slippage. This design isadvantageous for both a pulling and pushing motion through the handle12.

Still referring to FIG. 2, the handle 12 includes on the first face 18 arecess 23, such as a slot. The recess 23 has a proximal end 25, a distalend 27, and a floor 29. A raised stop 34 is located at the distal end 27of the recess 23 and projects away from the floor 29 of the recess 23.The recess 23 may be used to fit an accessory part such as a pusherassembly, which will be discussed in more detail later in connectionwith FIGS. 5 and 6.

The connection between the proximal end 22 of the shaft 14 and thedistal end 16 of the handle 12 may be permanent or reversible, i.e.,removable and reusable. Such a connection may be accomplished throughany suitable means, such as threading, chemical bonding, heat molding,gluing, tight-fitting, fastening, an O-ring fitting, and the like. Inone embodiment, the material for the handle 12 and the shaft 14 is thesame or compatible enough that the two are manufactured as one integralpiece. In other words, the delivery device 10 can include a shaft 14with an enlarged proximal end that serves as the handle 12.

The illustrative handle 12 may be attached to the shaft 14 in aparticular manner to select a desired orientation of the shaft 14. InFIG. 1, the shaft 14 is attached to the handle 12 such that the shaft 14curves toward the second face 19 of the handle 12. A particularorientation between the shaft 14 and the handle 12 allows an operator tocontrol the orientation of various parts of the shaft 14 inside apatient even when visualization is difficult or impossible.

Referring now to FIG. 3, a pusher assembly 30 can be incorporated intothe delivery device 10. The distal end 24 of the shaft 14 is marked by acircle “A” to indicate that it may include one or more connectors suchas the ones described below. In the illustrative embodiment of FIG. 3,the pusher assembly 30 includes a pusher tube 31, a pusher button 32,and a tongue 33 (shown in FIGS. 4 and 5). In the assembled state, thepusher tube 31 and the pusher button 32 are slidably moveable over theshaft 14. The pusher assembly 30 is interconnected with the handle 12,as explained below in connection with FIG. 5, through the tongue 33. Thepusher assembly 30 may be used, for example, to assist slidable removalor extension of a component slidably interfitted over at least part ofthe shaft 14.

Referring to FIGS. 4 and 5, the illustrative pusher assembly 30 includesa pusher tube 31, a pusher button 32, and a tongue 33. The pusher tube31 has a proximal end 35, a distal end 37, and a lumen 39, which extendsfrom the proximal end 35 to the distal end 37. The pusher button 32 hasa proximal end 41, a distal end 43, and a lumen 45, which extends fromthe proximal end 41 to the distal end 43 and which is in fluidcommunication with the lumen 39 of the pusher tube 31 when assembled.

The pusher tube 31 attaches at its proximal end 35 to the distal end 43of the pusher button 32. The pusher tube 3 I and the pusher button 32may form one integral component. Alternatively, the proximal end 35 ofthe pusher tube 31 may be placed within the lumen 45 of the pusherbutton 32 and be fixed by, for example, an adhesive to the surface ofthe lumen 45 of the pusher button 32.

Specifically referring to FIG. 4, the pusher tube 31 may be manufacturedfrom a metal, for example, stainless steel, or from suitable polymer,plastic or other materials that have sufficient durometer hardness tofunction as a pusher. In one embodiment, the lumen 39 of the pusher tube31 has a size and shape that substantially matches the cross section ofthe shaft 14 such that the pusher 31 fits closely around the shaft 14(shown in FIG. 3). The outer surface and/or the inner surface of thepusher tube 31 may be coated or implanted with a hydrophilic agent,and/or other coating, to reduce surface friction. Similarly, the lumen45 of the pusher button 32 may also be coated or implanted with ahydrophilic agent, and/or other coating or implantation, to reducesurface friction. Part or the entire outer surface and/or the innersurface of the pusher tube 31 and/or the inner surface of the pusherbutton 32 may, in some embodiments, be coated or implanted with one ormore pharmaceuticals, for example, with anesthetic, antiinflammatory,coagulating, anticoagulating, antibiotic or antimicrobial agents.

The pusher button 32 may assume any shape conducive to effecting motionto the pusher assembly 30. In the illustrative embodiment, parts of thepusher button 32, such as its proximal 41 and distal 43 ends are largerin cross-section than the pusher tube 31. And there is a reduceddiameter area 44 in between the two ends 41 and 43. The reduced diameterarea 44 is tapered and curved to allow easy identification and grasping(such as between two adjacent fingers on one hand, so that the pushercan be actuated while grasping the device with the same hand). In theparticular illustrative embodiment of FIG. 4, the proximal end 41 of thepusher button 32 has a substantially rectangular or square perimeter.One side of the rectangular perimeter of the proximal end 41 is attachedto the tongue 33.

The tongue 33 of the pusher assembly 30 has a proximal end 47, a distalend 49, and a body 48 extending therebetween. The body 48 has twoopposite surfaces: an inner surface 52 and an outer surface 54 (bettershown in FIG. 5), with the inner surface 52 facing the lumen 45 of thepusher button 32. The illustrative tongue 33 includes, at its proximalend 47, a projection 50, which has a baseline 56. The distance 58between the distal end 49 of the tongue 33 and the baseline 56 can bevaried through the manufacturing process.

Referring now to FIG. 5, the tongue 33 of the pusher assembly 30 issized and shaped to be slidably moveable inside the recess 23 on thefirst face 18 of the handle 12 with the inner surface 52 of the tongue33 facing the floor 29 of the recess 23. At least the proximal end 47 ofthe tongue 33 can slide back and forth in the directions indicated byarrows 55. Thus, an operator may slide the pusher assembly 30 a limiteddistance distally and proximally over the delivery shaft 14 (FIG. 3) byadvancing the pusher button 32 distally or withdrawing the pusher button32 proximally, respectively. The limit for distal advance of the pusherassembly 30 is set when the projection 50 of the tongue 33 is stopped bythe raised stop 34 on the handle 12 (see FIGS. 2 and 4).

Similarly, the limit for proximal withdrawal of the pusher assembly 30is set when the proximal end 47 of the tongue 33 is stopped within therecess 23 by the proximal end 25 of the recess 23. Thus, the pusherassembly 30 is limited to a fixed travel distance, i.e., the distance 58between the distal end 49 of the tongue 33 and the baseline 56 of theprojection 50 of the tongue 33 (see FIG. 4). The distance 58 may vary tosuit a particular clinical application of the delivery device 10. In oneembodiment, the distance 58 that the pusher assembly 30 can travel isapproximately one (1) inch (about 2.54 cm).

Another advantage of the illustrative pusher assembly embodimentillustrated here is that through the interaction between the projection50 of the tongue 33, the stop 34 of the handle 12, and the proximal end25 of the recess 23, as described above, the tongue 33 of the pusherassembly 30 remains in constant contact with the handle 12. As a result,the pusher button 32 is also prevented from rotating about the deliveryshaft 14.

Referring to FIG. 6, a recess 23′ similar to the described recess 23 onthe face 18 of the handle 12 is made on the other face 19 of the handle12. The recess 23′ also has a raised stop 34′ similar to the stop 34 inthe recess 23. And the tongue 33 is duplicated on the opposite side ofthe pusher assembly 30 as a second tongue 33′, i.e., the tongue 33′ alsohas a projection 50′ similar to the projection 50 on the tongue 33. As aresult, the projection 50′ of the second tongue 33′ slides between stop34′ and the proximal end 25′ of the recess 23′, simultaneously with theprojection 50 of the first tongue 33. The two-tongue configuration makesit even easier to operate the pusher assembly 30.

Referring now to FIGS. 7A, 7B, 8A and 8B, according to alternativeembodiments of the invention, a delivery device 57 includes a shaft 59(which may be a needle or non-needle element), a guide tube 60, and ahandle 61. In this particular embodiment, both the shaft 59 and theguide tube 60 are attached to the handle 61. The guide tube 60 has aproximal end 62 and a distal end 64, and can also function as a dilatortube. A tubular member or wall of the guide tube 60 forms a lumen thatallows the shaft 59 to slidably move inside the guide tube 60. The guidetube 60 may be made of a metal such as stainless steel or a plastic. Inone embodiment, the guide tube 60 is made of the same material as theshaft 59. The distal end 63 of the shaft 59 (FIGS. 7B and 8A), and thedistal end 64 of the guide tube 60 (FIGS. 7A and 8B) are both marked bycircles “A” to indicate that they may both include one or moreconnectors such as the ones described and illustrated in more detailbelow.

Specifically referring to FIGS. 7A and 7B, the handle 61 includes anactuator 66 operatively connected to the proximal end 62 of the guidetube 60. The connection between the actuator 66 and the proximal end 62of the guide tube 60 may be permanent or reversible (removable andreusable). The illustrative actuator 66 operates through a mechanicalinterconnection. However, in alternative embodiments, it may operatethrough electrical, chemical, magnetic, mechanical, or other suitablemechanism, separately or in combination. In one embodiment, the actuator66 includes a first set of threads (not shown) that interfits with asecond set of threads (not shown) in the guide tube 60. In theillustrative embodiment, the actuator 66 includes a mechanical sliderthat has at least two positions. In FIG. 7A, the actuator 66 is at itsdistal position, and the distal end 64 of the guide tube 60 ispositioned distal to the tip 67 of the shaft 59, for example, by about0.5 to about 2 inches. In FIG. 7B, the actuator 66 is at a proximalposition and resultantly withdraws the distal end 64 of the guide tube60 to be proximal to the tip 67 of the shaft 59. Through manipulatingthe actuator 66, the operator can choose to either shield or expose thetip 67 of the shaft 59 at different stages in an operation. Theillustrative guide tube 60 is longer than the shaft 59. However, inother embodiments, the guide tube 60 may be of the same or shorterlength than the shaft 59. In one embodiment, the guide tube 60 isseparate from, i.e., not attached to or connected with, the handle 61.

Specifically referring to FIGS. 8A and 8B, the actuator, for example,the slider 66, is instead operatively connected to the proximal end 46of the shaft 59. The proximal end 62 of the guide tube 60 may beconnected to the distal end 71 of the handle 61, for example, throughfrictional fitting, adhesive, threading, or the like. In FIG. 8A, theslider 66 is at its distal position. As a result, the tip 67 of theshaft 59 is exposed and at a position distal to the distal end 64 of theguide tube 60. In FIG. 8B, the actuator 66 is at a proximal position. Asa result, the tip 67 of the shaft 59 is withdrawn proximal to the distalend 64 of the guide tube 60 and shielded by the guide tube 60. Throughmanipulating the actuator 66, the operator can, similar to using theembodiment depicted in FIGS. 7A and 7B, choose to either expose orshield the tip 67 of the shaft 59 at different stages in an operation.

Referring now to FIGS. 9A and 9B, according to another illustrativeembodiment of the invention, the delivery device includes a guide tube73, a shaft 75 (which may be a needle or non-needle element), and ahandle 76. The handle 76 includes an axial lumen 70 extending between adistal opening 72 at the distal end of the handle 76 and with a proximalopening 74 at the proximal end of the handle 76. The axial lumen 70 ofthe handle 76 is sized and shaped so that at least the proximal end 78of the guide tube 73 is slidably moveable within at least part of theaxial lumen 70. In one embodiment, a proximal end 78 of the guide tube73 can slide through the proximal opening 74 of the handle 76. In analternative embodiment, the proximal end 78 of the guide tube 73 doesnot exit the proximal opening 74 of the handle 76 as a proximal part ofthe lumen 70 of the handle can be narrower or completely blocked towardsthe proximal end of the handle 76. In one embodiment, the handle 76 canbe pulled off the proximal end 78 of the guide tube 73.

The guide tube 73 has the proximal end 78, the distal end 64, anddefines a lumen 65 that allows the shaft 75 to slidably move inside thetube 73. The guide tube 73 may be made of a metal such as stainlesssteel, a polymer, plastic or other suitable material. In one embodiment,the guide tube 73 is made of the same material as the shaft 75. Theguide tube 73 may assume a shape substantially similar to that of theshaft 75. Additionally, it may be substantially rigid, semi-rigid,semi-flexible or flexible. The guide tube 73 may include one or morecurves.

The shaft 75 is slidably moveable inside the guide tube 73. At oneposition, the tip 83 of the shaft 75 is distal to the guide tube 73 andthus exposed. The distal end 84 of the shaft 75 is marked by a circle“A” to indicate that it may include one or more connectors such as theones described below. In one embodiment, the proximal end 87 of theshaft 75 includes a graspable structure, for example, a knob 77 or anenlarged end. By grasping the knob 77, the operator can insert orwithdraw the shaft 75 from the lumen 65 of the guide tube 73, throughthe proximal opening 74 of the handle 76. FIG. 9B illustrates therelative position between the shaft 75, the guide tube 73, and thehandle 76 through a cross-sectional view. There can be clearance (notshown) between any of the three structures.

Referring now to FIG. 10A, an illustrative guide tube 51 has openings onboth its distal end 53 and its proximal end 57. A lumen 44 is in fluidcommunication with both the ends 53, 57 of the guide tube 51. One ormore apertures 68 penetrate the wall of the guide tube 51 and are influid communication with the lumen 44. In one embodiment, the apertures68 penetrate the wall of the guide tube 51 between the convex 69 and theconcave 71 regions defined by the curve of the guide tube 51. Because ofthe apertures 68, if the distal end 53 of the guide tube 51inadvertently punctures an organ, such as the bladder, during theoperation, the operator would be alerted when he sees fluid from thepunctured organ, such as urine or blood, flowing out of the apertures68. Both the distal end 53 and the proximal end 57 of the guide tube 51,marked by circles “A”, may include a connector or one member of aconnector pair, to be described and illustrated in more detail below.

Referring to FIG. 10B, in one illustrative embodiment, the apertures 68are distributed along a longitudinal axis of the guide tube 51 such thatat least two complementary apertures 68 are equidistant from one end 53or 57 of the guide tube 51. Referring to FIG. 11, alternatively, theapertures 68 may be distributed in an alternating pattern along thelongitudinal axis of the guide tube 51. The apertures 68 can be anyshape, such as circular, elliptical, and slotted, for example. The edgesof the apertures 68 may be beveled or rounded to prevent abrasion ofsurrounding tissue during use of the delivery system inside a patient.

FIG. 12 illustrates one way to associate the guide tube 73 and thehandle 76. A setscrew 79 is positioned at the distal end 46 of thehandle 76 and extends into the axial lumen 70 of the handle 76. Thelumen 70 slidably receives the proximal end 78 of the guide tube 73. Thesetscrew 79 can be tightened to hold the guide tube 73 stationary, andloosened to remove the handle 76 from the guide tube 73. Alternatively,the guide tube 73 is associated with the handle 76 by any otherdetachable junction known in the art, such as a snap junction,threading, interference fit, for example. In other embodiments, theguide tube 73 is not detachable from the handle 76.

Referring to FIG. 13A, the delivery device 88 a includes a shaft 80 anda handle 81. In addition to the features and properties described above,the shaft 80, according to this embodiment of the invention, includes aplurality of curves, bends, or arcs distributed between its proximal end82 and the distal end 83. For example, the shaft 80 may describe two,three, four arcs or more. In one embodiment, for example, the shaft 80describes a first arc 84 next to the proximal end 82 and a second arc 85next to the distal end 83. The two arcs 84 and 85 can be adjacent eachother and form a continuous curvature resembling a wave with a peak anda valley, for example. Alternatively, the two arcs may not be adjacenteach other. In one embodiment, the multiple arcs 84 and 85 aresubstantially located in the same common plane.

The shaft 80, in one embodiment, tapers from its proximal end 82 to itsdistal end 83, with its widest part at its proximal end 82. In anotherembodiment, the shaft 80 is not tapered and maintains a substantiallyuniform outer diameter. In one particular embodiment, the shaft 80 isnot tapered and has an outer diameter of about 0.125 inches. The distalend 83 of the shaft 80 may include a tapered, for example, a conical,section 86 that leads to the tip 87. The tip 87 may be sharp, pointed,or blunt. In the depicted embodiment, the shaft 80 is a solid shaft, butmay be hollow or have a hollow portion.

FIG. 138 depicts a delivery device 88 b including a shaft 80 I attachedto a handle 81. The shaft 80 I includes a tubular member with an opening89 at its distal end 83′. The opening 89 is in fluid communication witha lumen 96. The distal ends 83 and 83 I of the shafts 80 and 80′ aremarked by circles “A” to indicate that they may include variousdifferent types of connectors. Illustrative connectors are described inmore detail below. Additionally, as with previously described deliverydevices, the handles 81 and the shafts 80 and 80 I may be permanently,or removably and reusably attached to each other.

Referring now to FIGS. 14-16, in alternative embodiments of deliverydevices 88 c, 88 d, and 88 e, in addition to describing multiple arcs 84and 85 along its length, the shaft 80 may further include an angled orfurther curved distal end 91 a, 91 b, or 91 c that is at an angle 97 a,97 b, or 97 c relative to an adjacent portion 98 of the shaft 80,according to the invention. In one embodiment, the angled distal end 91a, 91 b or 91 c is substantially straight. The adjacent portion 98 mayinclude part or all of one of the arcs, for example, arc 85 which formsa concave region relative to the angled distal end 91 a, 91 b or 91 c.Alternatively, the adjacent portion 98 may be substantially straight.The degree and flexibility of the angle 97 a, 97 b, or 97 c, and thelength of the angled distal end 91 a, 91 b, or 91 c of the shaft 80, maybe selected according to the surgical application so that the distal end91 a, 91 b, or 91 c of the shaft 80 and its adjacent portion 98 followor accommodate the contour of part of the patient's anatomy, forexample, the pubic bone. In one illustrative embodiment, the angle 97 a,97 b, or 97 c and the length of the angled distal end 91 a, 91 b, or 91c are pre-selected to conform to the front contour of the female pubicbones. For example, as illustrated in FIG. 14, the angle 97 a betweenthe distal end 91 a and its adjacent portion 98 of the shaft 80 isobtuse. Alternatively, as illustrated in FIG. 15, the angle 97 b isabout 90°, and as illustrated in FIG. 16, the angle 97 c is acute, forexample, about 60°. In other embodiments, the angle of the bent by thedistal end 97 a, 97 b, or 97 c can be greater than about 45°, or greaterthan about 60°. These angle embodiments may have advantages foraccommodating particular body anatomy, such as the outline of the publicbone. In one embodiment, the multiple arcs 84, 85, and the angled distalend 91 a, 91 b, or 91 c are all substantially located in the same commonplane. Preferably, the length of the angled distal end 91 a, 91 b, or 91c constitutes no more than about 10%, 20% or 25% of the entire length ofthe shaft 80 that is outside the handle 81.

In one embodiment, the angled distal end 91 a, 91 b, or 91 c is employedto deflect the shaft 80 over the patient's pubic bone. According to boththe suprapubic-to-vaginal approach and the pre-pubic-to-vaginalapproach, the angled distal end 91 a, 91 b, or 91 c of the shaft 80 ispreferably pointed toward the pubic bone and away from internal organs.

FIG. 17 depicts an alternative illustrative delivery device 90 aincluding a shaft 92 a and a handle 93 a. The shaft 92 a, at least inpart, describes an arc of a substantial degree, for example, no lessthan about 45, about 60, or about 90 degrees in various embodiments. Inone embodiment, the curve in the shaft 92 a forms a “C” configuration.

FIG. 18 depicts another alternative delivery device 90 b, including ashaft 92 b attached to a handle 93 b. The shaft 92 b describes a helicalcurve 94 of between one and two turns. However, the helical curve 94 mayinclude any suitable number of turns. The delivery devices 90 a and 90 bmay be used to perform a trans-obturator procedure to place an implantsuch as a sling for treating urinary incontinence as described in moredetail below.

II. Implants

The delivery devices described above may be used to deliver and placeany suitable implant, such as a sling assembly, at an anatomical site ina patient's body.

Without limitation, exemplary sling/sleeve configurations that may beoperable with illustrative embodiments of the invention may be found inU.S. patent application entitled Medical Slings, to Rao et al., AttorneyDocument No.: BSC-265, filed on even day herewith; U.S. patentapplication entitled Medical Slings, to Chu, Attorney Document No.:BSC-276, filed on even day herewith; U.S. provisional patent applicationentitled Surgical Slings, to Li et al., Attorney Document No.:BSC-279PR, filed on even day herewith, U.S. patent application entitledSystems, U.S. patent application entitled Medical Implant, to Chu etal., Attorney Document No.: BSC-255, filed on even day herewith, U.S.provisional patent application Ser. No. 60/403,555; U.S. provisionalpatent application Ser. No. 60/465,722; U.S. patent application Ser. No.10/460,112; and U.S. patent application Ser. No. 09/096,983, the entirecontents of which are incorporated herein by reference.

FIG. 19 depicts an illustrative sling assembly 11 including a sling 95and a sleeve 99 suitable for use with the previously described deliverydevices. The sling 95 may be formed, for example, from a strip of mesh,a network of fabric, a suture, a permeable, non-permeable, pourous,non-pourous, or any other material constructed for support orconstriction. Non-limiting examples of materials that can be employed tomanufacture the sling 95 include polypropylene, polyesters, polyolefins,polytetrafluoroethylene, polyethylene, polyurethanes, nylons, andco-polymers thereof as described in U.S. Pat. No. 6,042,592 (“BSC-163”),the disclosure of which is incorporated herein by reference. The sling95 may be formed natural tissues (such as human cadaveric, bovine,porcine, equine, etc.), or the sling may be formed from a hybrid ofsynthetic materials and natural tissues; and may contain featuresdescribed in coowned patent applications U.S. Ser. No. 09/916,983(“BSC-183”) and U.S. Ser. No. 10/460,112 (“BSC-246”), the entiredisclosures of both are incorporated by reference. The sling 95 may becoated, for example, with a pharmaceutical.

Optionally, the sling 95 may include rough edges containing projectionscalled tangs. The sling 95 may also have a partly de-tanged edge that isfree of any tangs. These and other optional features of the sling 95 aredescribed in co-owned U.S. patent application Ser. No. 10/092,872(“BSC-205”) and Ser. No. 10/093,498 (“BSC-190-1”), the entiredisclosures of both are incorporated herein by reference.

Still referring to FIG. 19, in certain embodiments, the sling 95 is atleast partly enclosed in a sheath envelope or envelope-like structure,such as the sleeve 99. In the illustrative embodiment, the sleeve 99fully encloses the sling 95, and the sling 95 is substantially freefloating in the sleeve 99. The sleeve 99 surrounding the sling 95reduces the likelihood that the sling 95 will become contaminated withforeign matter, such as bacteria, during the delivery and placementprocedure at an anatomical site. Additionally, the sleeve 99 providesadded structural integrity to the sling 95 so that the sling 95 does notget twisted, or over-stretched during the delivery process. The sleeve99 can also assist the operator in adjusting the position and tension inthe sling 95 during placement or implantation.

The sleeve 99 may be coated, for example, with a pharmaceutical on itsouter surface and/or its inner surface. Non-limiting examples ofmaterials that can be employed to manufacture the sleeve 99 includepolypropylene, polyethylene, polyester, polytetrafluoroethylene, orco-polymers thereof. The sleeve 99 may include tear features such asapertures to assist the operator in removing the sleeve 99 from thesling 95 after delivery. The sleeve may associate with other structuressuch as spacers, scaffolds, fasteners, tongues, and tabs that assist inthe delivery and placement of the sling assembly 11. These and otheroptional features of the sleeve 99 or other parts of the sling assembly11, including the sling 95, are described in co-owned U.S. patentapplications under Attorney Docket No. BSC-255 and under Attorney DocketNo. BSC-278 both entitled “Systems, Methods and Devices Relating toDelivery of Medical Implants,” both of which filed on even dateherewith, and the entire content of which is incorporated herein byreference.

The two ends 100 a and 100 b of the sleeve 99 may include structuressuch as tabs or dilators. Such structures can be made of the samematerial or a material different from the sleeve 99. In someembodiments, such material is selected to have more structural rigiditythan the sleeve 99. The two ends 100 a and 100 b of the sleeve 99 aremarked by circles “B” and “B′” to indicate that may include one or moreconnectors for connecting to the shafts, guides tubes, guide members,dilators and/or dilator tubes of delivery devices. Such connectors aredescribed in detail below. In embodiments where the sling assembly 11does not include the optional sleeve 99, the two ends 102 a and 102 b ofthe sling 95 may include structures such as tabs, dilators, andconnectors (also described below in detail).

FIG. 20 depicts an alternative sling assembly 101, including a sleeve105, formed from two sleeve portions 105 a and 105 b and only partlyenclosing the sling 95. In this embodiment, the sleeve portions 105 aand 105 b are separated and distinct and provide for an intermentportion of the sling 95 to be sleeveless. The two ends 102 a and 102 bof the sling 95 are fixedly attached to parts of the sleeve portions 105a and 105 b, for example, through heat bonding, a suture or any othersuitable mechanism. The two ends 107 a and 107 b of the sleeve 105 aremarked by circle “B” and “B′” to indicate that they may include one ormore connectors as described in detail below.

Referring now to FIG. 21, in another alternative embodiment, a slingassembly 103 includes a sleeve 104 that also partly encloses the sling95. The sling 95 is free floating inside the sleeve 104. The sleeve 104includes two separate portions 104 a and 104 b. However, the sleeveportions 104 a and 104 b are fastened to each other on one side througha fastener 106, for example, a tab. Alternatively, the one side of thesleeve portions 104 a and 104 b is one integral piece that can be formedinto a loop that is oriented within or around a fastener or spacer.Cutting across the fastener 106 allows the operator to remove thefastener 106 and the two sleeve portions 104 a and 104 b become separatefrom each other. Then, the operator can remove the sleeve portions 104 aand 104 b from the patient's body by pulling on two ends 108 a and 108 bof the sleeve portions 104 a and 104 b. A more detailed description ofthe fastener 106 and other means of fastening the sleeve portions 104 aand 104 b are provided in the co-pending U.S. patent application filedon the even date under attorney Docket No. BSC-278 and entitled“Systems, Methods and Devices Relating to Delivery of Medical Implants.”The two sleeve ends 108 a and 108 b, also marked by circle “B” and “B′”and to be shown in detail in subsequent figures, may include one or moreconnectors described below.

III. Connectors

Connectors can be used to interlock and/or attach various parts in adelivery system permanently or reversibly (i.e. removably and reusably).For example, connectors can be used to attach and/or interlock two ormore of the following: an implant or implant assembly (for example, asling assembly), a delivery device, or a guide member. Alternatively,connectors can be used to attach and/or interlock parts within the slingassembly, or within the delivery device, or within the guide member.Connectors may also serve additional functions besides the above, suchas dilation or tunneling.

Some exemplary sling/sleeve termination configurations and connectorsare disclosed in U.S. patent application Ser. No. 10/325,125; U.S.provisional patent application Ser. No. 60/418,827; U.S. provisionalpatent application Ser. No. 60/418,642; U.S. provisional patentapplication Ser. No. 60/434,167; and U.S. provisional patent applicationSer. No. 60/403,555; the disclosures of which are incorporated herein byreference.

Each pair of connectors typically includes two connector members; eachmay be located on a part of the delivery system, for example, the slingassembly, the delivery device, or the guide member. For ease ofreference, the part of the delivery system on which a connector islocated is referred to as the “base part.” A connector can be integralwith its base part, for example, the connector may be a slot, a reduceddiameter section, or an aperture in the base part or may be attached toits base part. Additionally, the connector may be made out of the samematerial as the base part, for example, through thermal extrusion ormolding.

A connector and its base part may be attached in a permanent, orreversible, (i.e., removable and reusable) fashion. Any suitablemechanism may be used to attach a connector with its base part, forexample, use of an O-ring or other fasteners, or use of heat bonding oran adhesive. For convenience of illustration, one member of eachconnector pair may be shown in the drawings as located on a particularstructure, for example, a sling assembly, but it should be understoodthat each member of a connector pair can be interchangeably located withthe other member of the pair.

FIGS. 22A-22D depict a connector pair 110 including a loop connector111, and a mating slotted receptacle connector 112. The illustrated loopconnector 111 includes a loop portion 113 at its distal end and a baseportion 115 at an opposite end, bridged by a neck portion 116, whichtapers inward from the loop portion 113 to the base portion 115.

In this illustrative embodiment, the loop connector 111 is located atthe sling assembly end 117. More particularly, the illustrated baseportion 115 of the loop connector 111 is attached to a dilator 118located at the sling assembly end 117. The base portion 115 may be, forexample, insert molded to the dilator 118 or bonded by any suitablemeans.

The loop connector 111 may be formed from any filament such as wire,cable or suture, which may be made, for example, of plastic, steel orany other suitable material, including a shape memory material. In oneembodiment, the loop connector 111 is rigid. In an alternativeembodiment, the loop connector 111 is not rigid, but has sufficientdurometer hardness to maintain a pre-selected shape. In a furtherembodiment, the loop connector 111 is malleable to fit the outline of aslot 120 after the connector 111 hooks onto the receptacle connector102. In yet another embodiment, the loop connector 111 is flexible. Theloop connector 111 may be of a variety of shapes, for example, circular,semi-circular, oval, triangular or rectangular. The entire loopconnector 111 can be made of a unitary material, or in sections.

The receptacle connector 112, in this illustrative embodiment, islocated at a shaft distal end 121 of a shaft 114 in a delivery device119. As shown, the connector 112 includes an L-shaped slot 120 formed inthe distal end 121. The connector 112 also includes two lateral grooves122 a and 122 b extending axially in a distal direction from theL-shaped slot 120 to the tip 123 of the distal end 121. The L-shapedslot 120 includes an entry slot 124 extending from a peripheral side ofthe shaft distal end 121 radially inwards. The L-shaped slot 120 alsoincludes a retention slot 125 extending axially in distal direction.

Referring specifically to FIG. 22B, the loop portion 113 of the loopconnector 111 fits into the slot 120 and the tapered neck portion 116interfits into the lateral grooves 122 a and 122 b. Preferably, thetapering of the neck portion 116 is shaped to match the tapering of theshaft distal end 121. This is illustrated in FIG. 22B where parts of theloop connector 111 are depicted in phantom lines. The tapered neckportion 116 is also sized to fit snugly in and interlock with the groves122 a and 122 b when the loop connector 111 and the slotted, receptacleconnector 112 are mated.

FIG. 22C is illustrative the mating process between the loop connector111 the receptacle connector 112. As depicted, the loop portion 113,which may be semirigid, is first hooked into the entry slot 124. Then,the shaft distal end 112 and/or the loop connector 111 are moved inaxially opposite directions, continuing into the retention slot 125. Theloop connector 111 is rotated in the direction shown by the arrow 126toward the lateral grooves 122 a and 122 b (FIG. 22B). Because the neckportion 116 of the loop connector 111 is shaped and sized to fit snuglyin the grooves 122 a and 122 b, the operator needs to force the neckportion 116 against the periphery of the shaft distal end 121 as herotates the loop connector III.

FIG. 22D shows the neck portion 116 fitted into the grooves 122 a and122 b (not shown) of the receptacle connector 112. The neck portion 116can be made, for example, of a material with some elasticity, forexample, a metal or a polymer, such that the neck portion 116 returns toits original size after having been expanded temporarily to enter thelateral grooves 122 a and 122 b. As a result, the neck portion 116 stayslocked inside the grooves 122 a and 122 b of the receptacle connector112. This orientation provides for a smooth transition from shaft tosling assembly, in an end-to-end interconnection, which minimizes edgesthat could produce tissue trauma. To disconnect the two connectors, theprocedure is simply reversed, i.e., the neck section 116 is forcedagainst the periphery of the shaft distal end 121 to expand temporarilyso that it can come out of the lateral grooves 122 a and 122 b (FIG.22B).

FIG. 23 depicts a loop connector 111 a interconnected with a receptableconnector 112 a, according to another illustrative embodiment of theinvention. The loop connector 111 a includes a loop 113 a that may be aflexible wire, suture, or cable, and may be made of, for example, apolymeric material or metal. The loop 113 a may be of single strand,multiple strands, or coated. In one embodiment, the filament that makesup the loop 113 a is between about 0.006 inch and about 0.016 inch indiameter.

In the illustrative embodiment, the loop connector 111 a is bonded tothe sling assembly end 117, specifically, a dilator 118. The receptacleconnector 102 a is illustrated as located on the shaft distal end 121 ofthe delivery device 119. In this illustrative embodiment, the receptacleconnector 112 a includes an axially extending indentation, channel orslot 120 a for retaining the loop 113 a.

FIG. 24 depicts a receptacle connector 112 b located on the shaft distalend 121 of a delivery device 119 according to another illustrativeembodiment of the invention. The receptacle connector 112 b includesslot 120 b, extending radially into the distal end of 121 axially in adistal direction. As depicted, the slot 120 b is curved. Optionally, thereceptacle connector 112 b also includes a section 127, which extendsaxially both distally and proximally.

FIG. 25 depicts a perspective view of a loop connector 128 that can beinterconnected with a slotted receptacle connector 132 according to analternative embodiment of the invention. In this illustrativeembodiment, the loop connector 128 attaches to a sling assembly end 129and the receptacle connector 132 is disposed on the shaft distal end121. The loop connector 128 includes a tubular member 130 with an axiallumen 131 extending from a distal opening 133. In one embodiment, thetubular member includes an optional axial opening 135 along the axiallumen 131. The tubular member 130 includes an internal loop 136, forexample, a bar across the lumen 131, that interconnect with a receptacleconnector.

The illustrative receptacle connector 132 includes a slot 137, forexample, an oblique notch, which may further include a protuberance 138.The protuberance 138 helps to prevent premature release of a capturedloop, for example, the internal loop 136 of the loop connector 128, asthe protuberance 138 serves as a barrier for the filament's exit. Theprotuberance 138 can be of any size or shape as long as it effectivelyrestricts the captured loop from exiting the slot 137, for example, bycreating a narrowing, a choke-point, or pinch-point 134, having anarrower width than that of the loop filament.

To interconnect the connectors 128 and 132, the operator slides theslotted receptacle connector 132 into the axial lumen 131 of the loopconnector 128, either through the distal opening 133 or the axialopening 135. Then the operator orients the connectors such that the slot137 on the connector 132 faces the internal loop 136 of the connector128. The operator slides the internal loop 136 into the slot 137, andforces the internal loop 136 past the protuberance 138 in the slot 137.The protuberance 138 then locks the internal loop 136 inside the slot137. Because the tubular member 130 of the loop connector 128 has asmooth cylindrical outer surface, having the internal loop 136 providesa smooth joint between parts of the delivery system that is advantageousfor dilation and tunneling through patient tissue.

FIG. 26 depicts an optional recessed or rounded edge 139 in a receptacleconnector 132 a. This feature tends to smooth the entrance to thereceptacle connector 132 a and reduce the likelihood of it catching ontissue. Additionally, the rounded edge 139 also increases the ease withwhich the receptacle connector 132 a captures a loop such as the loop113 a of the loop connector 111 a (described above in FIG. 23), into theslot 137 a. The slot 137 a may also include a locking mechanism, such asa protuberance 138 a.

FIG. 27 depicts a receptacle connector 146 including a slot 140 that isL-shaped. While the connector 146 may be attached to or disposed on anypart of a delivery system, in the illustrative embodiment, it is formedin the shaft distal end 121 of the delivery device 119. The slot 140includes two legs: an entry notch 141, and a retention slot 142. In theillustrative embodiment, the entry notch 141 is a cutout substantiallynormal to a longitudinal axis of the distal shaft end 121. In oneexemplary embodiment, the retention slot 142 is substantiallyperpendicular to the entry notch 106, and extends distally away from theentry slot 141. Further, the illustrative retention slot 142 is longerthan the illustrative entry slot 141, with advantages in retaining acaptured loop filament.

Both the entry slot 141 and the retention slot 142 can be of anydimension suitable to capturing a particular mating connector. In oneembodiment, the retention slot 142 is narrower than the entry slot 141,for example, to substantially match the outer diameter of the loopfilament in a mating loop connector such as the loop connector 111 a(FIG. 23). For example, if the outer diameter of the loop filament isabout 0.016 inches, the entry slot 141 may have a width 143 that isslightly wider, for example, about 0.018 inches, while the retentionslot 142 may have a uniform width 144 that is about 0.016 inches.Alternatively, the retention slot 142 may be tapered to become narrowertowards its distal end 145. For example, the retention slot 142 may betapered from 0.018 inches to about 0.016 inches towards its distal end145. A width 144 in the retention slot 142 that substantially matches oris less than that of the captured filament, for example, the loopportion 113 a of the loop connector 111 a (FIG. 23), is advantageous inretaining the filament after capture.

The retention slot 142 meets the entry slot 141 at an inside corner 147and outside corner 149. Both the inside corner 147 and the outsidecorner 149 can assume a variety of shapes, for example, they can besmooth, (e.g., rounded), or sharp (e.g., angled). In FIG. 27, theillustrative inside corner 147 is sharp while the outside corner 149 issmooth. A smooth corner is advantageous in capturing a filament while asharp corner may be advantageous in retaining the filament.

FIG. 28 depicts the slot 140 in an alternative receptacle connector 148having retention features in addition to the features described inconnection with the receptacle connector embodiment in FIG. 27.Specifically, the receptacle connector 148 has one or more protuberances150. The protuberance 150 may assume a variety of shapes. For example,the protuberance 150 may be hooked or straight, and may have flat orrounded edges, with flat or rounded transitions between edges. In theillustrative embodiment, the protuberance 150 is located on the insidecorner 147 and extends into the retention slot 142. However, in otherembodiments, it may be alternatively or additionally located at theoutside corner 149. Additionally, one or more protuberances 150 mayalternatively or additionally project into the entry slot 141. In oneembodiment, the protuberance 150 effectively imposes a choke point 151,which is the narrowest point in the slot 140, and is substantially thesame or narrower than the diameter of a loop filament of a mating loopconnector, for example, the loop portion 113 a of the loop connector 111a (FIG. 23). For example, if the loop filament is about 0.016 inches,the choke point 151 may provide about 0.014 inches of clearance. As aresult, after the loop filament is forced into the retention, slot 142past the protuberance 150, it is prevented from exiting the retentionsection 142 absent a force directing it past the protuberance 150 in theother direction.

The protuberance 150 may be manufactured to make it easier to enter theretention slot 142 while also making harder to exit the retention slot142. For example, the illustrative protuberance 150 has a rounded entrycorner 152 which an entering filament encounters. The rounded entrycorner 152 facilitates the capture of the filament by facilitating thefilament in its sliding into the retention slot 142. On the other sideof the protuberance 150, however, an exit corner 153 which an exitingfilament encounters, provides a sharp corner to make it harder for thefilament to escape. To further hinder exit, the protuberance 150 has asubstantially flat shoulder 154 facing the distal tip 123 of the shaft114.

The protuberance 150 can also be configured such that it effectivelyretains a captured connector permanently. For example, the choke point151 can be so narrow that to free a captured filament, the protuberance150 has to be broken off for the filament to exit the slot 140. Suchpermanent retention can also be effected through the geometry of theprotuberance 150.

FIG. 29 depicts a receptacle connector 155 including an entry slot 158and a substantially cylindrical retention section 157. According toanother alternative illustrative embodiment. In the illustrativeembodiment, receptacle connector 155 is disposed on the distal shaft end121. In a similar fashion to, previously discussed embodiments, theentry slot 156 extends radially into the distal shaft end 121. Thesubstantially cylindrical retention section extends axially through thedistal shaft end 121 and is located distally adjacent to the entry slot156. The retention 157 and entry 156 slots intersect at a reduced widthpassage 159 formed by the shoulder 158. The retention cylinder has adiameter or width that is larger than the diameter of a capturedfilament, for example, the loop 113 a of a loop connector 111 a, so thata section of the loop 113 a can reside in it. The shoulder 158 projectsinto the passage 159 between the reservoir 157 to impose a choke pointthat restricts the passage of a captured filament. The shoulder 158 maybe configured such that it effectively retains a captured connectorpermanently. Alternatively, the retention imposed by the shoulder 158may be temporary and can be overcome.

FIG. 30 depicts a receptacle connector 160 including a slot 162 forreceiving and retaining a filament, for example, the loop 113 a of theloop connector 111 a (FIG. 23). The illustrative receptacle connector160 is disposed on the shaft distal end 121. The optionally curved slot162 extends toward the distal tip 123 of the shaft distal end 121 hasone or more protuberances 164 a and 164 b in between. In the specificembodiment depicted, the protuberances 164 a and 164 b are each disposedon one side of the slot 162 and roughly equidistant from a distal end165 of the slot 162. Therefore, the illustrative protuberances 164 a and164 b are axially aligned relative to each other. The protuberances 164a and 164 b impose a choke point 166 in between them. The choke point166 serves to restrict loop filament movement within the slot 162. Inthe illustrative embodiment, the protuberances 164 a and 164 b arestepped shoulder portions. The protuberance 164 a and 164 b may eachhave a sharp exit corner (168 a, 168 b) to discourage filament exit. Anexample of the loop filament that can be employed is the loop 113 a ofthe loop connector 111 a (FIG. 23).

FIG. 31 depicts a receptacle connector 170 including a slot 171 wheretwo protuberances 172 a and 172 b are not equidistant to a distal end173 of the slot 171. Therefore, the illustrative protuberances 172 a and172 b are axially offset relative to each other. In the illustrativeembodiment, the two protuberances 172 a and 172 b are diposed in suchproximity that a choke point 174, the narrowest point in the slot 171,is the space or clearance between the two protuberances 172 a and 172 b.In the illustrated embodiment, each of the protuberances 172 a and 172b, are formed as a curved bump.

FIGS. 32A and 32B depict, respectively, a side view and a sideperspective view of a receptacle connector 178 including an entry notch179 joined to a retention slot 180. In the illustrated embodiment, theentry notch 179 is substantially straight, and the retention slot 180 iscurved. On one hand, a curved retention slot 180 may be advantageous inretaining a captured filament and preventing premature release becausethe curvature requires changes in direction as the captured filamentmaneuvers to escape. On the other hand, intended release of the capturedfilament may be accomplished with relative ease because an operator canmanually direct the movement of the captured filament through thecurvature of the slot 180. In the particular embodiment illustrated, theretention slot 180 comprises a half-circular arc that resembles a hook.

In one embodiment, the retention slot 180, as described earlier in otherembodiments, may have a width that is substantially the same or lessthan the diameter of the captured filament, such that movement of thefilament is restricted in the retention slot 180. In one embodiment, thefilament is immobilized as it is stuck in the narrow passage of theretention slot 180. Optionally, there may be one or more protuberancesalong the length of the retention slot 180, for example, at the insidecorner 181 where the retention slot 180 meets the entry notch 179. Asdescribed above, a protuberance assists in the retention of a capturedfilament.

FIG. 33 depicts a connector pair 183 including a loop connector 184 anda receptacle connector 185 before they become interconnected with eachother, according to one illustrative embodiment of the invention. Theloop connector 184 includes a loop 186 that is substantially of atriangular shape with an apex 187 and a base side 188. While the loopconnector 184 can be attached to any part of the delivery system, it isshown in this exemplary embodiment to be attached to an end 100 a of asleeve 99 of a sling assembly 11. For example, one end 100 a of thesleeve 99 is looped around the loop base side 188 and adhered to thesleeve end 100 a itself to effect the attachment. The ends of thefilament for the loop 186 may remain separated inside the sleeve end 100a, or they may be joined by welding or through a connector, such as ahypo-tube (not shown). The hypo-tube may be crimped to secure thefilament in place.

The loop filament 186 may be rigid or malleable. The substantiallytriangular shape of the loop 186 is advantageous for dilating tissuewhile passing through the body of a patient. According to a furtheradvantage, flatness of the loop 186 causes the resultant tunnel to berelatively two-dimensional, which helps to keep the sling assembly 11 inits flat configuration instead of getting folded or twisted whilepassing through the tunnel. A relatively flat dilator or tunneler mayalso be advantageous in aligning or orienting parts of the deliverysystem.

Still referring to FIG. 33, the receptacle connector 185 includes acurved slot 190. To interconnect the loop connector 184 with thereceptacle connector 185, the loop apex 187 of the loop connector 184first approaches the slot 190 in the receptacle connector 185. Afterentry into the slot 190, the loop 186 slides into a retention section192 and eventually resides close to the distal end 193 of the retentionsection 192.

FIG. 34 depicts a loop connector 194 including a loop filament 195 thatis at least partly embedded in the sleeve end 100 a of the slingassembly 11. An aperture 196 is defined at least partly by the embeddedloop filament 195. The aperture 196 can be of a variety of shapes, forexample, a triangular shape. The loop connector 194 shown in thisembodiment can interconnect with various embodiments of the receptacleconnectors, including the ones shown in all the previous figures, forexample, FIGS. 22A-33, in a manner similar to the embodiment describedin connection with FIG. 33.

FIGS. 35A and 35B, depict a connector 200 including a malleable portion202 that can be inserted into the slotted receptacle connector 185, andpreferably be retained after the malleable portion 202 changes its shapeor form. In the illustrated example where the connector 200 is attachedto the sleeve end 100 a of the sling assembly 11, the malleable portion202 includes part of the sleeve end 100 a that envelopes a loop filament204. The sleeve end 100 a is typically made of a soft, flexible plastic,and therefore, the shape and form of the connector 200 is largelydetermined by the shape and form of the loop filament 204. For example,the loop filament 204 may bend in a normal direction to the plane, inwhich the sleeve end 100 a resides, as indicated by the arrows 205.

During interconnections the malleable portion 202 enters the slot 190with its distal end 206 first. As the malleable portion 202 passesthrough the slot 190 into the retention section 192, the malleableportion 202 bends to conform to the curvature of the slot 190 until thedistal end 206 of the malleable portion 202 reaches the distal end 193of the retention section 192. The connector 185 can also be used tointerconnect with other slotted receptacle connectors described herein.

FIGS. 36A and 36B, depict, through a side perspective view and across-sectional view, a loop connector 210 with an adjustable loop 211.The loop connector 210 is illustrated as attached to a base part, forexample, the sling assembly 11. In one embodiment, the loop connector210 includes a housing 212 that at least partly encloses a lockingmechanism 214. A filament 215 that makes up the loop 211 is threadedinside the housing 212, for example, through a lumen 216, so that thelocking mechanism 214 can lock the loop 211 at a particular size as itsfilament 215 moves through the housing 212. Numerous structures can beused as the locking mechanism 214.

For example, in FIG. 36B, the illustrative locking mechanism 214includes a clip where one or more teeth 217 can engage each other tolock the positions of the loop filament 215. Engagement of the teeth 217may be prompted by compression of a spring loaded housing 212.Disengagement of the teeth 217, hence, release of the filamentpositions, may be prompted by a second action of compressing the housing212 where one or more springs 218 act to deactivate the lockingmechanism 214, for example, by disengaging the teeth 217. Anotherexample of the locking mechanism is a ratchet in which a pawl engagesthe sloping teeth of a wheel or bar, permitting motion in one directiononly.

FIGS. 37A and 37B depict the extended state and the retracted state,respectively, of the adjustable loop 211 of the loop connector 210 forinterconnection purpose. Referring specifically to FIG. 37A, the loop211 is typically at an extended state when a receptacle connector 220captures the loop 211 in a slot 219. To adjust the loop 211 to itsretracted state, the operator can pull both ends 222 a and 222 b of theloop filament 215. Alternatively, the operator can hold one filament end(222 a or 222 b) fast while pulling on the other filament end (222 b or222 a). Further alternatively, the operator can hold both filament ends222 a and 222 b fast and push the housing 212 towards the receptacleconnector 220. The size of the loop 211 can be reduced until the housing212 is in contact with the receptacle connector 220 as shown in FIG.37B. The locking mechanism 214 can be activated during this process tolock the loop 211 at a particular size. In the illustrative embodimentin FIG. 37B, the loop 211 is retracted until it wraps snugly aroundportions of the receptacle connector 220, including the distal end 223of the slot 219. At this point, the locking mechanism 214 (FIG. 36B) canbe activated to lock in the loop size such that the loop connector 210and the receptacle connector 220 form a snug joint so that they move asone piece.

To enlarge the size of the loop 211, the operator deactivate the lockingmechanism 214, then pulls the housing 212 away from the receptacleconnector 220 while holding the latter fast.

FIG. 38 depicts an alternative loop connector 225 including anadjustable loop 226 made from a filament 227 threaded through thehousing 212. One end 228 of the loop filament 227 is fixedly attached tothe housing 212 such that only the other filament end 229 is threadedthrough the lumen 216 and affected by the locking mechanism 214.Adjusting the size of the loop 226 is similar to the procedure describedin connection with FIGS. 37A and 37B, except that only one filament end229 is needed and available for manipulation.

FIGS. 39A-39C depict an illustrative connector pair 233 including a plugconnector 234 and a receptacle connector 236, which interconnect witheach other through a receptacle loop 235 in the receptacle connector236. The illustrative plug connector 234 is attached to the shaft distalend 121 of the delivery device 119. The illustrative plug connector 234has a reduced-diameter section 238 proximal to a conical, tapered distalsection 240. In the illustrative embodiment, the tapered distal section240 tapers towards a tip 241. The tip 241 may be blunt or sharp. Thetapered distal section 240 has its thickest point at its proximal base237 which is adjacent the reduced-diameter section 238. A diameter 239at the base 237 is larger than a diameter 243 of the reduced diametersection 238. The plug connector 234 may have a variety of shapes incross-sections along its length, for example, circular, oval,triangular, or rectangular.

The receptacle connector 236 is characterized by the receptacle loop235, which receives and retains the plug connector 234. The illustrativereceptacle connector 236 is attached to the sleeve end 100 a of thesling assembly 11. In other embodiments, the receptacle connector 236 isattached to other types of medical implants (not shown). In an exemplaryembodiment, the receptacle connector 236 includes an optional supportloop 242, which may be of a substantially triangular shape or of anyother suitable shapes. For purpose of attaching the receptacle connector236 with the sling assembly 11, the sleeve end 100 a may simply wraparound a base side 244 of the support loop 242, and be heat-bonded tothe sleeve end 100 a itself. The two ends of the support loop 242, whichmay therefore be embedded in the sleeve end 100 a, can remain separate,or joined by welding or through a hypo-tube (not shown). The hypo-tubemay add structural support when the support loop 242 is used in dilationor tunneling.

The helical receptacle loop 235 may be disposed at any location in thereceptacle connector 236, with any orientation. In the illustrativeembodiment, the helical receptacle loop 235 is located at the apex 245of the triangular support loop 242. Further, the illustrative helicalreceptacle loop 235 is oriented substantially normal to the plane wherethe support loop 242 resides. Such an orientation helps to facilitateend-to-end alignment between the distal shaft end 119 and the slingassembly 11. As discussed above, such alignment makes it easier totunnel the implant, such as the sling assembly 11, through patienttissue without twisting or king the sling assembly 11, and causes lesstrauma for the patient.

Since the receptacle loop 235 only needs a structure to support it, thefirst loop 242 can be replaced with any suitable support structure,without, deviating from the scope of the invention. For example, a rodor a solid, flat substrate with or without any aperture in it can easilyreplace the support loop 242. However, a loop structure, while can beused for support purpose, as described in previous embodiments, can alsobe used, much as a loop connector, to hook into a slot in a slottedreceptacle connector. Advantages from having a relatively flat dilatorlike the support loop 242, which is triangular is also described above.

In FIG. 39A, the illustrative receptacle loop 235 is formed, forexample, in a spiral or helical structure, by a filament, for example,the same filament that forms the triangular support loop 242. In onepreferred embodiment, the filament is a stainless steel wire with abouta 0.028 inch diameter. The receptacle loop 235 may include less than onecomplete loop, one loop, or more than one loop. In one preferredembodiment, the receptacle loop 235 is about 1.5 loops. The loop 235 mayassume any suitable shape, for example, circular, oval, triangular,rectangular or a horseshoe shape. In one embodiment, the filament thatmakes up both the first support loop 242 and the second receptacle loop235 has certain flexibility and elasticity. As a result, the operator,by pressing or squeezing both sides of the triangular support loop 242,for example, at “release regions” 246 a and 246 b, which are regionsadjacent the apex 245 of the triangular loop 242, can enlarge the sizeof the receptacle loop 235 where the filament crosses over to form thereceptacle loop 235, such as in the illustrated embodiment. Once theoperator stops squeezing the release regions 246 a and 246 b, itselasticity in the filament causes the receptacle loop 235 to return toits original size. Such a feature is useful for initial mating andsubsequent releasing of a connector.

FIGS. 39B and 39C depict at least two ways to interconnect the plugconnector 234 with the receptacle connector 236. Specifically referringto FIG. 39B, in a head-on approach, the two distal ends of theconnectors 234 and 236 start the interconnecting process by facing eachother. Then, the distal tapered section 240 of the plug connector 234,with the tip 241 first, enters the receptacle loop 235 and into thespace above the support loop 242. In one embodiment, the receptacle loop235, in its relaxed state, has an inner diameter smaller than thediameter of the thickest point in the tapered distal section 240 of theplug connector 234. As described earlier, however, the tapered section240 can ply and expand the receptacle loop 235 where allowed by theflexibility of the loop filament. Once the entire distal section 240passes the receptacle loop 235, the receptacle loop 235 drops into thereduced-diameter section 238. As dictated by the elasticity in itsfilament, the receptacle loop 235 returns to much of its original sizeand therefore is retained in the reduced-diameter section 238.

An advantage of this embodiment of the connector pair is that, oneconnector can easily rotate about its longitudinal axis while remaininginterconnected with the other connector but without rotating the otherconnector. This allows an operator to unwind twisted base parts, forexample, the sling assembly 11. This type of head-on interconnection canbe useful in implanting a urinary sling using the so-called “top-down,”supra-pubic, pre-pubic, or trans-obturator approach.

Specifically referring to FIG. 39C, in an alternative “backend”approach, the interconnecting process starts with the distal tip 241 ofthe plug connector 234 behind the receptacle loop 235 and above thesupport loop 242. Then, with the tip 241 first, the distal taperedsection 240 of the plug connector 234 enters the receptacle loop 235from the space above the triangular support loop 242. Similar to thehead-on approach, once the distal section 240 of the plug connector 234passes the receptacle loop 235 of the receptacle connector 236, thereduced-diameter section 240 in the plug connector 234 engages thereceptacle loop 235. As a result, the plug connector 234 remainsinterconnected with the receptacle connector 236. This type of backendconnection can be useful in implanting a urinary sling using theso-called “bottom-up,” trans-vaginal, or trans-obturator approach.

To disconnect the connectors, as described in connection with FIG. 39A,the operator can squeeze both sides of the triangular support loop 242of the receptacle connector 236, for example, at the release regions 246a and 246 b, to temporarily expand the receptacle loop 235 for releasingthe plug connector 234.

FIGS. 40A-41C depict receptacle connectors 247 and 248, both includingreceptacle loops 249 and 250 that resemble U-shaped horseshoes. Both theillustrative receptacle connectors 247 and 248 can employ the plugconnector 234 of the type previously described with respect to FIG. 39A.Specifically referring to FIG. 40A, a support loop 252 supports thereceptacle loop 249 of the receptacle connector 247. Further, theillustrative receptacle connector 247 including the support loop 252 andthe receptacle loop 249 is made of a single filament.

FIG. 40B depicts an enlarged top view of the distal portion of thereceptacle connector 247. In the illustrative embodiment, the width 251of the loop 249 can be measured as the curvature 253 from the center ofthe loop to two unconnected ends 254 a and 254 b. The curvature 253 ispreferably between about 270 and about 360 degrees. Additionally, thereceptacle loop 249 resides in a plane that is at an angle 255 to theplane of the support loop 252. The angle 255 is preferably about 90degrees, but may be anywhere between 0 and 180 degrees. Both thecurvature 253 and the angle 255 of the horseshoe receptacle connector247 can be varied to accommodate a wide range of shapes of mating plugconnectors, and to accommodate variations in operative procedures.

FIG. 41A depicts an alternative embodiment 248 of the horseshoereceptacle connector 247. In the embodiment of FIG. 41A, the supportstructure of the receptacle loop 250 includes a narrowed neck portion258 extending between the receptacle loop 250 and the triangular supportloop 256. Again, the entire illustrative receptacle connector 248 ismade from a single filament. In the narrowed neck portion 258, the twoopposite sides 258 a and 258 b are arranged substantially in paralleland are closer together than the diameter of the receptacle loop 250.

The narrowed neck portion 258 reduces the likelihood of prematurerelease of a captured plug connector such as the plug connector 234.More specifically, the narrowed neck portion 258 helps to preventunintended expansion in the receptacle loop 250 because its lengthserves to dissipate any expansive force transferred from the supportloop 256, for example, when the sides of the support loop 256 aresqueezed during dilation. This advantage of the narrowed neck portion258 is especially apparent when the receptacle loop includes a filamentcross-over such as the 1.5-turn helical structure depicted in receptacleloop 235 (for example, FIG. 39A). This is because the filamentcross-over, much like the pivot in a pair of scissors, causes one sideto open up when the other side closes. Accordingly, the feature of anarrowed neck portion in combination with other receptacle loopstructures, such as the one depicted in FIG. 39A is specificallycontemplated by this invention.

A second advantage of having the neck portion 258 is illustrated throughFIGS. 41B and 41C, which show the plug connector 234 and the receptacleconnector 248 interconnected in a head-on (or in-line) approach and abackend approach, respectively. Interconnection between a plug connectorand horseshoe receptacle connector under either approach is similar towhat is described in connection with FIGS. 39B and 39C except that thecircular receptacle loop 235 has been replaced with a horseshoe-shapedreceptacle loop, for example, 249 or 250. As shown by FIGS. 41B and 41C,because there is little space within the narrowed neck portion 258, itserves as a physical barrier against the plying of the tapered distalsection 240 (FIG. 41B) or a base section 260 (FIG. 41C) of a capturedplug connector 234. As a result, the narrowed neck section 258 serves asa locking mechanism.

FIG. 42A depicts a further embodiment of a plug connector 261 and areceptacle connector 262. In the illustrated embodiment, the receptacleconnector 262 is attached to the sleeve end 100 a of the sling assembly11. The plug connector 261 is attached to a guide tube 264. The guidetube 264 slidably interfits over a handled shaft 265.

The plug connector 261 includes a tapered distal section 269 and a basesection 270, bridged by a circular notch 271. The distal section 269 ofthe plug connector 261 tapers towards a distal tip 272, which may besharp or blunt. In the illustrative embodiment, the distal section 269is of a conical shape. The illustrative base section 270 is over moldedto a distal end 273 of the guide tube 264. In another embodiment, thebase section 270 is attached to a distal end of the shaft 265. The basesection 270 and other parts of the plug connector 261 may be made of avariety of materials, for example, polymers such as acrylonitrilebutadiene styrene (ABS).

The receptacle connector 262 includes a relatively flat substrate 275.The substrate 275 is preferably of a thickness that is less than orequals the length of the circular notch 271 in the plug connector 261.The sleeve end 100 a may be heat bonded, molded or otherwise attached tothe substrate 275. The substrate 275 has an eyelet or aperture 277. Theaperture 277 may have a rim (not shown) around it. In a preferredembodiment, the aperture 277 is of a size slightly smaller than thecross-section of the thickest point in the distal section 269 of theplug connector 261.

To interconnect the plug connector 261 with the receptacle connector262, the plug tip 272 enters the aperture 277 first. The rest of theplug distal section 269 is then forced through the aperture 277 untilthe substrate 275 drops into the plug connector 261's circular notch 271in a “snap-on” action. The interconnection can take either the head-onapproach or the backend approach as described above. In the particularapplication where the plug connector 261 is attached to a guide tube264, the shaft 265 may first be inserted into the guide tube 264 to givesupport for the interconnection.

FIG. 42B depicts an alternative embodiment of a plug and receptacleconnector pair including the plug connector 261 and an alternativereceptacle connector 280. The illustrative plug connector 261 isdisposed at the distal end 121 of the shaft 114. The receptacleconnector 280 includes an elongated substrate 281 extending from a firstdistal end 282 to a second proximal end 283. A lateral aperture through284 is located in the substrate end 282. The substrate end 283 attachesto the dilator 118 of the sling assembly end 117. In one embodiment, theelongated substrate 281 is strap-like (i.e., narrow, flat, andelongated) and is bendable, but has sufficient tensile strength to bepulled through the patient's tissues. The elongated substrate 281 has alength that is substantially greater than conventional embodiments ofreceptacle connectors used to interconnect the delivery device and thesling assembly. In one embodiment, the elongated substrate 281 is atleast about 8 inches, which is longer than the typical length between alower abdominal incision and the anterior vaginal wall (not shown) of apatient. In one embodiment, the elongated substrate 281 is made of aflexible plastic. In another embodiment, the elongated substrate 281 ismade of a malleable metal.

The plug connector 261 can be interconnected with the receptacleconnector 280 in a way similar to the method described in connectionwith FIG. 42A, e.g., by forcing the plug distal section 269 into theaperture 284 until the substrate 281 advances into the reduced diametersection 271. In an exemplary procedure, a percutaneous passage betweenthe anterior vaginal wall and a lower abdomen incision is required fordelivery of a sling assembly. In an embodiment where the elongatedsubstrate 281 spans the length of that percutaneous passage, the shaft114 and an interconnected receptacle connector 280 can travel the entirelength of the percutaneous passage before the dilator 118 has to enterthe patient's tissue. As a result, less drag is created in the patient'stissue and the stress or tension at the connection point between thereceptacle connector 280 and the plug connector 261 is reduced by thestress otherwise created by dilation. Once the shaft 114 passes throughthe patient's tissue, the operator may then separate the receptacleconnector 280 from the plug connector 261. The operator can pull theremaining portions of the receptacle connector 280, together with thedilator 118 and the rest of the sling assembly, through the patient'stissues. At this time, the dilation takes place and the resultanttension on connector pairs falls on an attachment site 285 between theproximal connector end 283 and the dilator 118. Because a permanent orotherwise more durable attachment can be manufactured with respect tothe attachment site 285 beforehand, the attachment site 285 is morelikely to withstand the tension brought by the dilation process than theinterconnection between connectors 280 and 261, especially if thatinterconnection is reversible. Accordingly, the elongated substrate 281reduces the risk of separation between two interconnected parts during atrans-percutaneous procedure.

FIGS. 43 and 44 depict alternative embodiments 261 a and 261 b to theplug connector 261. Each of the alternative embodiments (261 a, 261 b)has a distal section (269 a, 269 b) that is separated from a basesection (270 a, 270 b) by an reduced-diameter section (271 a, 271 b).The reduced-diameter section (271 a, 271 b) functions much like thereduced diameter section 271 of the plug connector 261 described inFIGS. 42A and 42B, and they can substitute each other for purpose ofthis invention. In FIG. 43, the illustrative distal section 269 aincludes a bulbous head and the illustrative reduced-diameter section271 a is a circular notch or a stepped-down portion. In FIG. 44, theillustrative distal section 269 b includes a spearhead and theillustrative reduced diameter section 271 b includes multiple valleys286.

FIG. 45 depicts a connector pair 289 including a plug connector 290 anda receptacle connector 291 where the plug connector 290 alternatelycontracts and expands to interlock with the receptacle connector 291.The illustrative plug connector 290 is attached to the distal end 121 ofthe shaft 114 of the delivery device 119. The illustrative receptacleconnector 291 is attached to the sleeve end 100 a of the sling assembly11. The plug connector 290 includes a distal section 292 and anreduced-diameter section 293, for example, a circular notch, which isdisposed between the distal section 292 and the rest of the shaft 114.In one illustrative embodiment, the reduced-diameter section 293 is astepped-down portion of the shaft 114, and the plug connector 290 ismade out of the same material as and formed integrally with the rest ofthe shaft 114. However, in other embodiments these components may bemade from different materials and attached together using any suitableapproach. Optionally, one or more slits 295 are disposed along at leastpart of the distal section 292 of the plug connector 290, substantiallyparallel to a long axis of the shaft 114. In the illustrativeembodiment, the slits 295 extend to the tip 296 of the plug connector290 and therefore, the tip 296 of the plug connector 290 is hallowed.Although the illustrative embodiment employs four slits 295, any numbermay be used. There may be any number of slits 295, for example, four.The slits 295 allow the distal section 292 to compress inwardly. If thematerial that makes up the distal section 292 has sufficient elasticity,for example, as is the case with many metals and plastics, the distalsection 292 will return to its relaxed and more expanded configurationonce the compressive force disappears.

The illustrative receptacle connector 291 attaches to the sleeve end 100a through an extension tongue 294. The illustrative tongue 294 iselongated and spaces the receptacle 297 away from the sleeve end 100 a.This makes it easier for the operator to interfit the plug connector 290with the receptacle connector 291 using the head-on approach or thebackend approach. In one embodiment, the tongue 294 is between about 0.5inch to about one inch long.

The receptacle connector 291 includes a receptacle 297 for receiving andretaining the plug connector 290. In one embodiment, the receptacle 297is tubular and includes a lumen 301 extending between first 300 andsecond 302 axially spaced apertures. The receptacle 297 has a length 304that is preferably less than or equal to the length of thereduced-diameter section 293 of the plug connector 290.

In one embodiment, the lumen 301 in the receptacle connector 291 has asmaller diameter than the thickest point in the distal section 292 ofthe plug connector 290 and/or the thickest point on the shaft 114. Tointerconnect the two connectors, the tip 296 of the plug connector 290enters the receptor lumen 301 through either the distal opening 300(head-on approach) or the proximal opening 302 (backend approach) of thereceptacle 297. The slits 295 constrict and compress as the thickerportion of the distal section 292 of the plug connector 290 as itsqueezes into the receptor lumen 301. However, when the plug distalsection 292 passes through the receptacle 297 to radially align thereceptacle 297 with the reduced-diameter section 293 of the plugconnector 290, the plug distal section 292 expands and returns to itsrelaxed configuration, acting as a barrier for separation from thereceptacle connector 291.

FIG. 45 also depicts a release tool 306, for separating and releasingthe receptacle connector 291 from the plug connector 290. The releasetool 306 includes a first end 307, a second end 308, a lumen 310, and anopening 311 on the second end 308 in fluid communication with the lumen310. Optionally, the release tool 306 may also have a second opening(not shown) in fluid communication with the lumen 310, however, for thepurpose of this invention, the lumen 310 only needs one opening 311. Thediameter of the illustrative lumen 310 in the release tool 306 issubstantially similar to the diameter of the lumen 301 of the receptacle297. Preferably, the length of the lumen 310 is greater than or equal tothe length of the plug distal section 292. In a preferred embodiment,the lumen 310 in the release tool 306 is of a conical shape with theopening 311 being the base of the cone.

To separate the receptacle connector 291 from the plug connector 290,the operator slides the release tool 306, through its opening 311, firstover the tip 296 and then over the distal section 292 of the plugconnector 290. The lumen 310 of the release tool 306 contracts andcompresses the plug distal section 292 as the release tool 306 advancesover it. Once the plug distal section 292 is substantially inside thelumen 310, the receptacle 297 can slide over the now compressed distalsection 292 towards the tip 296 of the plug connector 290. This motionreplaces the receptacle connector 291 with the release tool 306.Accordingly, the release tool 306 and the receptacle connector 291 areremoved, in tandem, from the distal section 292 of the plug connector290. This disconnection procedure works for interconnected connectorswhether they were interconnected through a head-on or backend approach.

FIG. 46A depicts a plug connector 314 and a receptacle connector 315where the receptacle connector 315 alternately expands and contracts tointerlock with the plug connector 314. The illustrative plug connector314 is disposed at the shaft distal end 121 of the delivery device 119.The plug connector 314 includes a distal section 316 that tapers to atip 317 and an reduced-diameter section 318, for example, a circularnotch, which is disposed between the distal section 316 and the rest ofthe shaft 114. The tapered distal section 316 has a proximal base 324adjacent the reduced-diameter section 318. The tapered distal section316 reaches its maximum diameter 333 at the proximal base 324. Themaximum diameter 333 in the tapered distal section 316 is larger thanthe diameter 335 of the reduced-diameter section 318. The diameter 338for the shaft distal section 121 is also larger than the diameter 335 ofthe reduced-diameter section 318. The illustrative distal section 316 ofthe plug connector 314 is conical in shape and includes telescopedsections 336 and 337.

The illustrative receptacle connector 315 is attached to the sleeve end100 a of a sling assembly. The receptacle connector 315 has a tubularportion 320 with a free and enlarged head portion 321. The illustrativehead portion 321 is substantially conical. One or more slits 322 aredisposed along the head portion 321 and optionally, part of the tubularportion 320, substantially parallel to a long axis of the receptacleconnector 315. In one embodiment, the slits 322 extend to the verydistal end 323 of the receptacle connector 315. There may be any numberof slits 322. In the illustrative embodiment, four slits 322 results infour axial projections 326 a, 326 b, 326 c, and 326 d. For example, theaxial projections 326 a, 326 b, and 326 c extend from their respectivebase portions 331 a, 331 b, and 331 c to their respective enlarged head332 a, 332 b, and 332 c. The base portions 331 a, 331 b and 331 c, andthe base portion (not shown) of the projection 326 d, together form partof the radial structure of the receptacle tubular portion 320. Theenlarged heads 332 a, 332 b, 332 c, and 332 d (of the projection 326 d),which extend radially outward from the receptacle connector 315,together form the substantially conical head portion 321 of thereceptacle connector 315.

FIG. 46B depicts a cross-sectional end view of the distal end 323 of thereceptacle connector 315. Each of the slits 322 extends radially fromthe periphery of the head portion 321 to an axial channel 325. Thechannel 325 radially circumscribed by the enlarged heads 332 a-332 d andthe axial projections 326 a-326 d. When the enlarged heads 332 a-332 dexpand radially outward, the channel 325 expands as well, and thechannel diameter 327 increases. Although the channel 325 is depicted asbeing generally cylindrical in shape, any suitable shape for mating withthe plug connector 314 may be employed. Once the expansive force isremoved, the head portion 321 returns to its relaxed and less expansivestate, and the channel diameter 327 returns to its smaller, defaultvalue.

FIGS. 46C and 46D depict two exemplary embodiments of receptacleconnectors 315 and 315 a, where the channels 325 and 325 a extend fromopenings 330 and 330 a at the head portions 321 and 321 a into thetubular portions 320 and 320 a respectively. One or more protuberances328 or 328 a are disposed inside the channel 325 or 325 a, for example,in the tubular portion 320 (FIG. 46C), or in the head portion 321 a(FIG. 46D). In the illustrative embodiments, the protuberance 328 or 328a is an annular ring with an axial length 334 or 334 a that is less orthe same as the reduced diameter section 318 (FIG. 46A) of the plugconnector 314. The channel diameter 339 or 339 a between the annularprotuberance 328 or 328 a is less than the maximum diameter 333 of theplug distal section 316 (FIG. 46A) and/or the diameter 338 of the shaftdistal end 121 (FIG. 46A). Preferably, the diameter 339 or 339 a isgreater than or equal to the diameter 335 of the reduced-diametersection 318 of the plug connector 314 (FIG. 46A). The channel diameter327 or 327 a in the rest of the channel 325 or 325 a is substantiallythe same or larger than both the diameter 333 of the plug distal section316 and the diameter 338 of the shaft distal end 121.

To interconnect the plug connector 314 with the receptacle connector315, for example, the operator slides the distal opening 330 of thereceptacle connector 315 over the tip 317 and then the distal section316 of the plug connector 314. The plug distal section 316 travelsfurther into the receptacle channel 325 until stopped by theprotuberances 328. However, because of the slits 322, which preferablyextend to the protuberance 328, the channel 325 expands further to allowthe distal section 316 of the plug connection 314 to pass theprotuberance 328 so as to engage the protuberance 328 with thereduced-diameter section 318. Because the diameter 339 at theprotuberance 328 is selected to be less than the diameter 333 of theplug distal section 316 or the diameter 338 of the shaft distal end 121,the protuberance 328 locks the plug connector 314 inside the receptacleconnector 315.

FIG. 47 depicts a cross-sectional view of the connector pair accordingto another illustrative embodiment of the invention. The connector pairif FIG. 47 includes a plug connector 234 of the type previouslydescribed with respect to FIG. 39A. The connector pair also includes areceptacle connector 352. The receptacle connector 352 includes atubular member 358 and a tightening collar 366. The tubular member 358includes an inner wall 363 which defines a receptacle 360. The innerwall 363 includes an annular shoulder 364 which protrudes radiallyinward from and extends around the inner wall 363 to define a housingopening 362. The tightening collar 366 interfits concentrically aroundthe tubular member 358. In some embodiments, the tubular member 358includes axially extending slits (not shown) disposed around itscircumference to enhance its ability to expand and contract.

In some embodiments, the tubular member 358 is made from a semi-rigid orflexible material and the tightening collar 366 is made from asubstantially rigid material.

To interconnect the plug connector 234 with the receptacle connector352, with the tightening collar 366 in the unlocked state of FIG. 47,inserts the plug connector 234 into the opening 362 until the annularshoulder aligns with 364 the reduced-diameter section 238. Then, theoperator slides the tightening collar 366 in the proximal directionindicated by arrow 368 to compress the tubular member 358 around theplug connector 234. Referring now to FIG. 48, once the tightening collar366 is slid over the tubular member 358 and a portion of the distal end121 of the shaft 114, the lumenal diameter in the tubular member 358 isreduced such that the shoulder 364 engages the reduced diameter section238 and locks the tapered distal section 240 of the plug connector 234in place. To release the plug connector 234 from receptacle 360, theabove procedure is reversed: the second collar 366 is slide in thedistal direction opposite the arrow 368.

FIG. 49A depicts an exploded view of portions of the plug connector 380and a receptacle connector 382. The plug connector 380 attaches to or isan integral part, for example, of the shaft distal end 121 of thedelivery device 119. The plug connector 380 includes, from its distaltip 383, a conical distal section 384, a cylindrical section 386, and areduced-diameter section 388. The cylindrical section 386 includesproximal base 381 adjacent the reduced-diameter section 388. The conicaldistal section 384 and the cylindrical section 386 constitute a tipsection 385. The tip section 385 reaches its maximum diameter 387 at theproximal base 381, which is larger than the diameter 395 of thereduced-diameter section 388. Accordingly the maximum diameter 387, inthis illustrative embodiment, is also the maximum diameter of the plugconnector 380. The diameter 395 of the reduced-diameter section 388 isalso smaller than the diameter 397 of the shaft distal end 121.

The receptacle connector 382 includes a first portion 390 and a secondportion 392. In one embodiment, the second portion 392 includes one ormore rails 394. The rails 394 may extend along the full length of thesecond portion 392, or, alternatively, only partially along the lengthof the second portion 392. The first portion 390 includes grooves orslots 396 complementary to the rails 394 on the second portion 392.Portions 390 and 392 can assume a variety of shapes. For example, asillustrated, the first portion 390 may resemble part of a box, while thesecond portion 392 may resemble part of a tube. The two portions can, ofcourse, assume similar shapes.

Referring now to FIG. 49B, the first portion 390 of the receptacleconnector 382 includes a protuberance 398 that complements or conformsto at least a substantial part of the reduced-diameter section 388 inthe plug connector 380, illustratively about half of thereduced-diameter section 388. Accordingly, the protuberance 398 may be,for example, semi-annular in shape.

To interconnect the receptacle connector 382 with the plug connector380, the operator, in one embodiment, places the first portion 390 ofthe receptacle connector 382 on the plug connector 380. The protuberance398 mates with the reduced-diameter section 388 of the plug connector380. Then, the operator, matching the rails 394 with the slots 396,slides the second portion 392 onto the first portion 390, in thedirection indicated by arrow 399. The first portion 390 and the secondportion 392 should be sized such that when they are slid together, withthe help of the protuberance 398 inside the first portion 390, theyeffectively prevent the captured plug connector 380 from exiting. Torelease the plug connector 380 from the receptacle connector 382, theoperator slides the second portion 392 of the receptacle connector 382in the direction opposite the arrow 399 and separates the second portion392 from the first portion 390. Then, the first portion 390 and the plugconnector 380 are free to separate from each other.

In an alternative embodiment, to interfit the first portion 390 with thesecond portion 392, rather than sliding the rails 394 of the secondportion 392 into the complementary slots 396 of the first portion 390,the operator snaps the rails 394 into the complementary slots 396 toforce-fit the second portion 392 onto the first portion 390.

FIG. 50A depicts a plug connector 400 and an opened receptacle connector402 where the receptacle connector 402 locks the plug connector 400inside when a lid portion 406 of the receptacle connector 402 closes.The plug connector 400 is attached to, for example, the shaft distal end121 of the delivery device 119. The plug connector 400 includes one ormore reduced-diameter sections 404A and 404B.

The receptacle connector 402 includes a lid portion 406 and a bodyportion 408 linked by, for example, a longitudinal hinge 410 thatenables the lid portion 408 to open and close in a radial direction. Inits closed configuration (not shown), the receptacle connector 402 maysubstantially match the shape of the plug connector 400. For example, ifthe plug connector 400 is substantially cylindrical, the receptacleconnector 402, in its closed configuration, may be substantially tubularwith at least one opening 412 through which the shaft distal end 121 canextend. The receptacle connector 402 may further include a snappingmember 414 positioned on the lid portion 406 and a locking member 415positioned on the body portion 408. The body portion 408 of thereceptacle connector 402 includes one or more projections orprotuberances 416 a and 416 b that complements or conforms to asubstantial part of the reduced-diameter sections 404 a and 404 b, forexample, half of the reduced-diameter sections 404 a and 404 b.Accordingly, the protuberances 416 a and 416 b may each be, for example,semi-annular in shape. Optionally, the lid portion 406 may includesimilar protuberances 417 a and 417 b to complement its half of thereduced-diameter sections 404 a and 404 b. In one embodiment, theinterior of the receptacle connector 402 is molded to mirror the entirecontour of the plug connector 400, much like the box of a musicalinstrument would typically form-fit the instrument.

To interfit the receptacle connector 402 over the plug connector 400,the operator first opens the two portions 326, 328 of the receptacleconnector 402 to the illustrated open configuration. The operator thenplaces the plug connector 400 in the lumen 411 of the body portion 408of the receptacle connector 402 such that the protuberances 416 a and416 b of the body portion 408 mate with the reduced-diameter sections404 a and 404 b. To lock the plug connector 400 inside the receptacleconnector 402, the operator rotates the lid portion 406 in the directionindicated by arrow 413 onto the body portion 408 and snaps the snappingmember 414 into the locking member 415. To release the plug connector400, the operator reverses the aforementioned steps.

FIG. 50B depicts an alternative receptacle connector 402 a that can alsolock the plug connector 400 (described above with respect to FIG. 50) byclosing a lid portion 406 a. The receptacle connector 402 a includesfeatures similar to those of the receptacle connector 402, describedwith respect to FIG. 50, except that a lateral hinge 410 a replaces thelongitudinal hinge 410. The lateral hinge 410 a is located along aportion of the circumference of the receptacle connector 402 a, linksthe lid portion 406 a and the body portion 408 a, and enables the lidportion 406 a to open and close in an axial direction.

FIGS. 51A and 51B depict, through a perspective side view and across-sectional view, a receptacle connector 1352 having a protuberance1362 that facilitates interlocking with plug connector 380 of the typepreviously described with respect to FIG. 49A. The receptacle connector1352 includes a substantially tubular housing 1356 open at least at oneend 1357 for receiving the plug connector 380. The tubular housing 1356includes one or more apertures 1358. In the illustrated embodiment, twoapertures 1358 a and 1358 b extend axially along the tubular housing1356. A protuberance 1362 extends radially into the housing 1356.

In one embodiment, the length 1366 of the protuberance 1362 is less thanor equal to the depth of the reduced-diameter section 388 in the plugconnector 380. In the illustrative embodiment, the protuberance 1362 isa retractable or spring-loaded pin. In an alternative embodiment, theprotuberance 1362 is a flap made of a moldable material, such as, forexample, rubber, and is capable of being bent or displaced uponinsertion of the plug connector 380, as described in more detail below.In one embodiment, the flap is insert molded to the inner surface of thetubular wall 1360 of the receptacle connector 1352. In anotherembodiment, the flap is a cutout portion of the tubular wall 1360 thatremain attached to the tubular housing 1356 through a hinge, whichenables the operator to rotate the flap up and down, as explained belowin connection with FIG. 52.

In one embodiment, the receptacle 1364 in the tubular housing 1356 has adiameter 1365 that is equal to or less than the maximum diameter 387 ofthe plug connector 380. However, because the locking function by theprotuberance 1362 the receptacle 1364 may have a diameter larger thanthe maximum diameter 387 of the plug connector 380. In the latterembodiment, the tubular housing 1356 does not need to have any of theapertures 1358 a or 1358 b.

To interfit the receptacle connector 1352 over the plug connector 380,the operator inserts the tip 383 of the plug connector 380 into theopening at the end 1357 of the receptacle connector 1352. As theoperator advances the plug connector 380 further into the receptacle1364, the apertures 1358 a and 1358 b in the tubular housing 1356 allowthe receptacle 1364 to expand and accommodate the tapered distal section384 and the cylindrical section 386 of the plug connector 380.Alternatively, if no apertures 1358 are present on the receptacleconnector 1352, the operator force fits the plug connector 380 into thereceptacle 1364 of the receptacle connector 1352.

In an embodiment where the protuberance 1362 is a spring-loaded pin, theprotuberance 1362 is initially biased to project radially into thereceptacle 1364. As the operator advances the plug connector 380 intothe receptacle 1364, the tapered distal section 384 of the plugconnector 380 gradually deflects the protuberance 1362, either axiallyor radially. After the entire tapered distal section 384 and thecylindrical section 386 pass the protuberance 1362, the protuberance1362 returns to its original untensioned position in the adjacentreduced-diameter section 388 in the plug connector 380. By engaging withthe reduced diameter section 388, the protuberance 1362 locks the plugconnector 380 inside the receptacle connector 1352.

In an embodiment where the protuberance 1362 is manually retractable, itcan be initially retracted as the operator advances the plug connector380 into the lumen 1364 of the receptacle connector 1352. When thereduced-diameter section 388 in the plug connector 380 reaches theprotuberance 1362, the operator can let the protuberance 1362 extend orsimply fall back into the receptacle 1364 to engage the reduced-diametersection 388, thereby locking the plug connector 380.

In an embodiment where the protuberance 1362 is a flap, for example,insert molded to the inner surface of the tubular housing 1356 of thereceptacle connector 1352, the flap can be bent and displaced by theoperator inserting the plug connector 1234 into the receptacle 1364. Theflap rides along the surface of the plug connector 380 until it reachesthe reduced-diameter section 388 of the plug connector 234, at whichpoint it engages the reduced-diameter section 388, locking the plugconnector 234.

FIG. 52 depicts an embodiment of the receptacle connector 1352, in whicha receptacle connector 1352 a includes a protuberance that is a flap1368 attached to the tubular housing 1356 a through a hinge 1370. Insome embodiments, the flap 1368 may be formed as a cutout of the tubularhosing 1356 a. The operator initially deflects the flap 1368 in thedirection indicated by arrow 1372, and holds the flap 1368 coplanar withone side of the tubular housing 1356 a. The operator then advances theplug connector 380 into the receptacle 1364 a. When the reduced-diametersection 388 of the plug connector 380 is aligned with the flap 1368, theoperator deflects the flap 1368 in the direction opposite the arrow 1372to engage the reduced-diameter section 388, thereby locking the plugconnector 380. The operator may use any suitable tool to accomplish theflap deflection.

FIG. 53 depicts a receptacle connector 1382 that can be side mountedonto the plug connector 380 of the type previously described withrespect to FIG. 49A. The illustrative receptacle connector 1382 includesa cylindrical tubular member 1390 defining a channel 1392. The tubularmember 1390 has a first end 1391 that can attach to a part of a deliverysystem, for example, a sling assembly end (not shown), and a second end1393. A slot 1394 extends axially in the tubular member 1390 from thefirst end 1391 to the second end 1393. The illustrative slot 1394exposes a channel 1392 and has a width 1396 that is less than or equalto the diameter 395 of the reduced-diameter section 388 of the plugconnector 380. The illustrative slot 1394 has a length that is less thanor equal to that of the reduced-diameter section 388. Optionally, in oneembodiment, the channel 1392 has a diameter that is greater than orequal to that of the reduced-diameter section 388.

To interconnect the receptacle connector 1382 with the plug connector380, the operator aligns the slot 1394 with the reduced-diameter plugsection 388. The operator then interfits the reduced-diameter section388 through the slot 1394 into the channel 1392. Then the tubular member1390 snaps onto the reduced-diameter section 388 as the slot 394 returnsto its normal width to lock the plug connector 380 into the receptacleconnector 1382.

After the two connectors 1380 and 1382 have been interconnected, theoperator can rotate either the connector 1380 or 1382 about alongitudinal axis without rotating the other connector and whilemaintaining the interconnection. This is advantageous where a base part,for example, the sling assembly, attached to either connector needs tobe untwisted after getting twisted or wound during the delivery orplacement.

FIGS. 54A and 54B depict a receptacle connector 1410 where an axiallyextending receptacle 1412 includes a radially enlarged portion 1414 foraccommodating the tip section 385 of the plug connector 380 previouslydescribed with respect to FIG. 49A.

The illustrative receptacle connector 1410 includes a substantiallytubular housing 1416 with a distal opening 1418. The housing 1416 canattach to a component of a delivery system such as a sling assembly (notshown) through its proximal end 1420. The illustrative proximal housingend 1420 does not contain any proximal opening, but in an alternativeembodiment, there can be such an opening. Better shown in FIG. 54Bthrough a longitudinal view, the receptacle 1412 extends axially from adistal opening 1418 into the housing 1416. The receptacle 1412 includesan enlarged portion 1414 and a narrow portion 1422. A substantiallyannular ring 1424 with a shoulder 1415 projects from an inner wall 1426and narrows the receptacle 1412 to its narrow portion 1422. The narrowportion 1422 is similar to the channel 1392 described with respect toFIG. 53 and for receiving the reduced diameter section 388 of the plugconnector 380 (FIG. 49A). The enlarged portion 1414 is sized and shapedto receive the tip section 385 of the plug connector 380 (FIG. 49A).

Referring specifically to FIG. 54A, an axial slot 1428 extends radiallyfrom the housing outer surface 1430 into the receptacle 1412.Corresponding to and aligned with the enlarged receptacle portion 1412and the narrow receptacle portion 1422, the illustrative axial slot 1428includes an enlarged portion 1432 and a narrow portion 1434. Theenlarged slot portion 1432 and the narrow slot portion 1434 are narrowerthan the tip section maximum diameter 387 and diameter 395 of thereduced diameter section 388 of the plug connector 380 (FIG. 49A),respectively, for locking the plug connector 380. In an alternativeembodiment, the slot 1428 has uniform width.

Side-mounting the receptacle connector 1410 onto the plug connector 380is similar to the steps described above in connection with FIG. 53except that at least part of the plug connector 380 is snapped into theenlarged receptacle portion 1412 through the enlarged slot portion 1432.

FIG. 54C depicts an additional method of interfitting the receptacleconnector 1410 with the plug connector 380, as it may be advantageous touse this method during certain delivery procedures. The operator insertsa part of the tip section 385 of the plug connector 380 into theenlarged slot portion 1432 at an angle, with the reduced-diametersection 388 above the narrow slot portion 1434. The operator moves theshaft 114 in a clockwise direction indicated by the arrow 1406 towardsthe receptacle connector 1410. Through this motion, the operator snapfits the reduced-diameter section 388 of the plug connector 380 throughthe narrow slot portion 1434 into the narrow receptacle portion 1422(FIG. 54B), and the tip section 385 through the enlarged slot portion1432 into the enlarged receptacle portion 1414 (FIG. 54B).

FIG. 55 depicts a schematic view of a receptacle connector 1410 a whichis an alternative embodiment to the receptacle connector 1410. Thereceptacle connector 1410 a includes a tubular housing 1416 a formedfrom a substantially tubular wall 1417, and defines an enlargedreceptacle portion 1414 a and a narrow receptacle portion 1422 a. Thereceptacle connector 1410 a also includes an enlarged slot portion 1432a, aligned with the enlarged receptacle portion 1414 a, and a narrowslot portion 1434 a, aligned with the narrow receptacle portion 1422 a.In this embodiment, the slot portion 1432 a overhangs the enlargedreceptacle portion 1414 a, both axially and radically, and the slotportion 1434 a overhangs the narrow receptacle portion 1422 a axially.In some embodiments, the enlarged receptacle portions 1414 a is sized tobe axially longer than the plug connector tip section 385. In suchembodiments, subsequent to mating and in response to exerting axiallyopposing forces on the plug 380 and receptacle 1410 a connectors, thetip section 385 slides axially in the direction indicated by an arrow1408 under the overhang 1417 a and 1417 b. The tip section 385 stopswhen its base 381 abuts shoulders 1415 a and 1415 b of the enlargedreceptacle portion as indicated in phantom and becomes locked in place.

In other embodiments, the receptacle portions 1414 a and 1422 a aresized as are their counterparts 1414 and 1422 of FIG. 54B, and theoverhangs of the slot portions 1432 a and 1434 a have reduced lengthand/or width relative to their counterparts 1432 and 1434 of FIG. 54Band/or relative to the receptacle portions 1414 a and 1422 a. In all theabove embodiments, the overhangs provide further more secureinterlocking between the plug connector 380 and the receptacle connector1410 a, and reduce the likelihood of inadvertent separation.

The receptacle connector 1410 a further includes an enlarged slotportion 1432 a and a narrow slot portion 1434 a similar to the enlargedslot portion 1432 and the narrow slot portion 1434, respectively (FIG.54B). However, the enlarged slot portion 1432 a and the narrow slotportion 1434 a are not aligned with but offset from their counterpartreceptacle portions 1414 a and 1422 a. Portions 1417 a and 1417 b of thetubular wall 1417 narrows the slot space radially outside distal parts1440 a and 1440 b of the enlarged receptacle portion 1414 a such thatthe narrow slot portion 1434 a is longer than its counterpart 1434 inconnector 1410.

The receptacle connector 1410 a is mounted on the plug connector 380 aswith the receptacle connector 1410. However, the operator can move theshaft 114 in a direction indicated by an arrow 1408 to move the tipsection 385 into the roofed distal parts 1440 a and 1440 b of theenlarged receptacle portion 1414 a until the base 381 abuts shoulders1415 a as indicated by phantom line. As a result, the interconnectionbetween the two connectors 380 and 1410 a is more secure than betweenconnectors 380 and 1410.

FIG. 56A depicts another receptacle connector 419 which interfits, withthe plug connector 380 described previously with respect to FIG. 49A.After they are interfitted, both connectors 419 and 380 can rotateindependently while maintaining interfitted. In the illustrativeembodiment of the plug connector 380, the reduced diameter section 388has substantially the same length as the receptacle connector 419.

The receptacle connector 419 includes a cylindrical housing 421 with afirst 425 and second 423 ends. Preferably, the end 423 attaches to apart of a delivery system such as a medical implant. The housing 421includes a transverse aperture 418 that extends from a top surface 420of the connector 419 to a bottom surface 422. The receptacle connector419 further includes a first channel 424 on the top surface 420 and asecond channel 426 on the bottom surface 422. The first channel 424extends from the transverse aperture 418 to the first housing end 425,and the second channel 426 extends from the transverse aperture 418 tothe second housing end 423. The illustrative housing 421 includes anoptional cavity 428 that extends from an opening 430 at the secondhousing end 423 axially toward the first end 425. The cavity 428preferably is dimensioned and shaped to accommodate the tip section 385of the plug connector 380. In the illustrative embodiment, the cavity428 terminates at a back-wall 432.

FIG. 56B depicts a cross-sectional view of the housing 421 of thereceptacle connector 419, showing the first channel 424. FIG. 56C is across-sectional view of the housing 421 showing the second channel 426at a point between the transverse aperture 418 and the back wall 432.FIG. 56D is a cross-sectional view of the housing 421 showing the secondchannel 426 and the cavity 428. As depicted in FIG. 56B-56D, the firstchannel 424 includes a first substantially cylindrical receptacle 436,and the second channel 426 includes a second substantially cylindricalreceptacle 438. Both receptacles 436 and 438 are sized and shaped toaccommodate the reduced-diameter section 388 of the plug connector 380.Specifically, the diameter 437 of the first receptacle 436 and thediameter 439 of the second receptacle 438 are both greater than or equalto the diameter 395 (FIG. 56A) of the reduced-diameter section 388. Afirst axial opening 427 in the housing top surface 420 provides accessto the first channel receptacle 436. A second axial opening 429 in thehousing bottom surface 422 provides access to the second channelreceptacle 438. Both the first and second axial openings 427 and 429 arenarrower than the diameter 395 of the reduced-diameter section 384 tolock the reduced-diameter section 388 within the receptacles 436 and438.

Referring back to FIG. 56A, to interfit the plug connector 380 withinthe illustrative receptacle connector 419, the operator inserts the plugtip section 385 through the transverse aperture 418 from the top surface420 to the bottom surface 422. After the reduced-diameter section 388emerges from the bottom surface 422, the operator rotates the shaft 114relative to the receptacle connector 419 in the direction indicated byarrows 434 a and 434 b. The reduced-diameter section 388 snap fits intothe first and second receptacles 436 and 438, while the proximal base381 of the tip section 385 fits into the cavity 428.

In response to axially opposing forces on the interfitted connectors 419and 380, as indicated by the arrows 440, the plug tip section 385 backsinto the housing cavity 428 until the base 381 of the tip section 385abuts the back wall 432. This further locks the plug connector 380inside of the receptacle connector 419.

FIG. 57 depicts a threaded plug 442 connector and receptacle 444connector pair according to another illustrative embodiment of theinvention. The illustrative plug connector 442 is depicted as beingattached to or located at the distal end 121 of the shaft 114 in thedelivery device 119, and the illustrative receptacle connector 444 isdepicted as being attached to the sleeve end 100 a of the sling assembly11. However, as previously discussed the plug 442 and receptacle 444connectors may be located on any delivery system component.

The receptacle connector 444 includes a threaded receptacle 446 havingan opening 447. The receptacle 446 includes, on its inside wall 449, afirst set of threads 448. The plug connector 442 includes a second setof corresponding threads 450 diposed around its periphery. Theillustrative plug connector 442 optionally includes a conical distalsection 452. To interfit the plug connector 442 with the receptacleconnector 444, the operator positions the distal opening 447 over theplug distal section 452 and screws (i.e., rotates or threads), the firstset of threads 448 onto the second set of threads 450. To separate theconnectors 442 and 444, the operator rotates receptacle 444 and the plug442 connectors in a counter clockwise direction relative to each other.

FIGS. 58A and 58B depict an illustrative plug 380 and receptacle 454connector pair in which the receptacle connector 454 includes anadhesive surface 456. Preferably, illustrative adhesive surface 456 issealed with a protective layer 458, which may be removed prior to use.The receptacle connector 454 further includes an optional support 462.While the illustrative support 462 is a substantially cylindrical, itcan be of any other suitable shape. The illustrative support 462attaches, through its proximal end 463, for example, to the sleeve end100 a. The adhesive surface 456 can be disposed anywhere on the support462, for example, as in the illustrative embodiment, at its distal end460. In the illustrative embodiment, the adhesive surface 456 includetwo adhesive flaps 456 a and 456 b that are diametrically opposed toeach other, forming a pair of adhesive surfaces substantially normal tothe support 462.

Referring now to FIG. 58B, to interconnect the receptacle connector 454with the plug connector 380, the operator peels off the protective layer458 or otherwise removes it to expose the adhesive surface 456. Theoperator then interfits the plug 380 and receptacle 454 connectors andfolds down the two adhesive flaps 456 a and 456 b such that they wraparound the plug connector 380. A plug connector of any shape can beemployed with the receptacle connector 454 and the same embodiment,extended onto and/or around the distal shaft end 121. In a preferredembodiment, the plug connector 380 and/or the shaft distal end 121include a roughened surface or contours to facilitate bonding to theadhesive flaps 456 a and 456 b. The receptacle adhesive surface 456 canbe used, for example, to form a non-detachable (e.g., non-reusable)connection between a medical implant and another delivery systemcomponent.

FIGS. 59A and 59B depict a receptacle 464 and plug 380 connector pairthat interfit through a spring-loaded mechanism. The receptacleconnector 464 includes a substantially tubular housing 468 with threeportions: a distal portion 468 a and a proximal portion 468 b, axiallyseparated by an intermediary portion 468 c. The intermediary portion 468c includes a wall portion 466 with one or more through apertures 470 aand 470 b. The illustrative receptacle connector 464 also includes twospring members 472 a and 472 b mounted on or formed integrally with thedistal housing portion 468 a. Each spring member 472 a and 472 b has onits respective proximal end 473 a and 473 b a protuberance 474 a and 474b. In a rest state, the protuberance 474 a extends into the aperture 470a and the protuberance 474 b extends into the aperture 470 b. A coaxialtube 478 slidably fits over the distal housing portion 468 b and the twospring members 472 a and 472 b. The coaxial tube 478 provides anexemplary mechanism for securing the spring members 472 a and 472 baround the distal housing portion 468 a.

The tubular member 468 has a tubular cavity 469 into which theprotuberances 474 a and 474 b radically project. The tubular cavity 469is sized and shaped to accommodate the plug connector 380. The distance480 between the two spring protuberances 474 a and 474 b, when thespring members 472 a and 472 b are not tensioned, is less than themaximum diameter 387 of the plug tip section 385, but no less than thediameter 395 of the reduced-diameter section 388.

Referring now to FIG. 59B, to interfit the two connectors 464 and 380,the operator slides the distal housing portion 468 a over the tipsection 385 of the plug connector 380. In response to the distal section385 of the plug connector 380 advancing into the intermediary portion468 c, the spring protuberances 474 a and 474 b are forced to expandradially outward via the apertures 470 a and 470 b. However, when thereduced diameter section 388 aligns with the apertures 470 a and 470 b,the spring protuberances 474 a and 474 b spring back into the cavity 469and engage the reduced-diameter section 388. With the reduced diametersection so engaged, the operator can slide the coaxial tube 478 over theproximal spring ends 473 a and 473 b to lock the spring members 472 aand 472 b in place.

FIG. 60 depicts a receptacle 495 connector and a plug 503 connector pairthat mate through a keying feature according to another illustrativeembodiment of the invention. The illustrative plug connector 503 isattached to or otherwise located, for example, at a distal end 492 of adelivery shaft 494. Shown in a cross-sectional view, the illustrativereceptacle connector 495 is attached, for example, to an end of a slingassembly 11.

The illustrative receptacle connector 495 includes a substantiallycylindrical receptacle 496 having a distal opening 500. A cavity 499extends axially from the distal opening 500 into the receptacle 496. Aninside wall 498 of the receptacle 496 includes a projection 502 thatprojects radially into the cavity 499. An internal projection, such asthe projection 502, is advantageous in a surgical procedural includingsling placement procedures because it will not catch tissue.Consequently, the internal protuberance 502 makes it easier to tunnelthrough tissue and reduces tissue trauma. The protuberance 502 mayassume any shape and size that allows it to fit into a mating slot 490in the plug connector 503. The illustrative protuberance 502 has asubstantially rectangular longitudinal cross-section for ease of use,there may be a marking 501 on the outside of the receptacle 496 toindicate the location of the protuberance 502.

The plug connector 503 includes a slot 490 that extends axially towardsa shaft distal tip 505. The slot 490 has an access terminal 506 in aconical tip section 504. The tapering of the conical tip section 504allows a key element, such as the protuberance 502 in the receptacleconnector 495, to enter or exit the slot 490. The illustrative slot 490is substantially J-shaped and includes three distinct legs 490 a, 490 b,and 490 c. While all three illustrative legs 490 a, 490 b, and 490 c aresubstantially straight, any number of them may be curved. Eachillustrative leg 490 a, 490 b, and 490 c meets its adjacent leg at abouta right angle, although other angles are contemplated by the inventionas well. Traveling between the access terminal 506 and a lockingterminal 508 of the slot 490 requires a substantially 180-degree reversein travel direction. Optionally, other retention features describedherein can be combined with the present feature. For example, the slotsection 490 c may narrow towards the locking terminal 508 such that theprotuberance 502 is immobilized at the terminal 508. Alternatively, alocking protuberance such as those described in connection with FIG. 25,28, 30, or 31 can be incorporated in the slot 490 for retaining acaptured key element, such as the protuberance 502.

To interfit the receptacle-plug connector pair 495 and 503, theoperator, with the visual aid of the marking 501 on the outside of thereceptacle 496, aligns the internal protuberance 502 with the accessterminal 506 of the slot 490. The operator then slides the receptacleopening 500 over the plug tip 505, and advances the plug distal section504 into the receptacle cavity 499. The protuberance 502 slides into theaccess terminal 506 of the slot 490 and travels axially the length ofthe first leg 490 a. Then, the operator rotates the receptacle connector495 in the direction indicated by an arrow 512 to travel the length ofthe second slot leg 490 b. Finally, the operator pulls back thereceptacle connector 495 in the direction indicated by an arrow 510 totravel the length of the final leg 490 c, and lock the protuberance 502,adjacent to the end 508 of the leg 490 c. To unlock the connector 495from the connector 503, the operator performs the above described stepsin reverse.

FIGS. 61A and 61B depict a connector pair 516 and 530 that mate throughan internal clip-like protuberance 514 and a roofed slot 538 accordingto another illustrative embodiment of the invention. The illustrativereceptacle connector 516 is attached, for example, to the sling assembly11. The illustrative plug connector 530 is attached to or otherwisedisposed at, for example, a distal end 532 of a delivery shaft 534.

An illustrative receptacle connector 516, depicted in longitudinalcross-section, includes a substantially cylindrical receptacle 518. Acavity 520 extends from an opening 522 axially into the receptacle 518.The internal protuberance 514 has a base 521 attached to or integrallyformed with an inside wall 525 of the receptacle 518. The protuberance514 may assume a variety of shapes and orientations. In the illustrativeembodiment, the protuberance 514 resembles a clip with a clip tip 523projecting towards an end 524 of the cavity 520. The illustrativeprotuberance 514 extends substantially axially resulting in an elongatedspace 526 between the protuberance 514 and the inside wall 525. Theinternal protuberance 514 may be made of an elastic material. There maybe a marking 528, which may be a paint mark, on the outside of thereceptacle 518 to indicate the location and orientation of theprotuberance tip 523.

Referring to FIG. 61B, the mating plug connector 530 includes the slot538 for capturing and retaining the internal protuberance 514. Theillustrative slot 538 extends axially from a proximal end 544 to adistal end 543. The slot distal end 543 is under an overhang 531. Theoverhang 531, the slot distal end 543, and a slot floor 546 form aretention space 548 in the slot 538. An outer surface 536 of theoverhang 531 is ramped downward toward the slot 538 and provides easyentrance into the slot 538. An outer surface 540 also ramps downwardtoward the slot 538 at the slot proximal end 544. The ramped surface 540provides exit from the slot 538. Both ramped surfaces 536 and 540 canoptionally include steps (not shown). The slot 538 is at least as longas the internal protuberance 514, so that the entire protuberance 514can fit inside it. In an alternative embodiment, the slot 538 passesthrough from a first side 548 to a second side 550 of the connector 530.

To interfit the receptacle connector 516 with the plug connector 530,the operator, in one exemplary method and with the aid of the marking528 on the outside of the receptacle connector 516, aligns the internalprotuberance 521 with the distal end 541 of the ramped surface 536. Theoperator then slides the cavity opening 522 of the receptacle connector516 over the conical section 535 of the plug connector 530, and advancesthe plug connector 530 into the receptacle cavity 520. During theadvancement, the internal protuberance 514 starts to slide down theramped surface 536 into the slot 538, until the protuberance base 521 isstopped by the proximal slot end 544. Then, the operator reverses hismotion and pulls the receptacle connector 516 in the direction indicatedby an arrow 550 so that the protuberance tip 523 slides into theretention space 548 in the slot 538. Meanwhile, the overhang 531 entersthe elongated space 526 next to the protuberance 514. With theprotuberance 514 and the overhang 531 projecting in the oppositedirections, they interlock and thereby interlock the connectors 516 and530.

FIG. 62 depicts an open loop 552 and a plug 556 connector pair accordingto another illustrative embodiment of the invention. The illustrativeopen loop connector 552 is attached, through a proximal bridge 558, forexample, to the sling assembly 11. The illustrative plug connector 556is attached to or otherwise located, for example, at a distal end 571 ofa delivery shaft 574.

The illustrative loop connector 552 is formed from a single filament554, and includes a first leg 560 b and a second leg 560 b. The two legs560 a and 560 b are joined at their proximal ends 557 a and 557 b toform the C-shaped proximal bridge 558. Extending distally from thebridge 558, the two legs 560 a and 560 b cross, but do not couple to,each other at a crossing point 562, and terminate in ends 564 a and 564b of the two legs 560 a and 560 a, respectively. Each of the ends 564 aand 564 b includes a hooks 566 a, 566 b, respectively. The hooks 566 aand 566 b, at a relaxed state, approach each other, with or withoutcontacting each other. In the illustrative embodiment, there is a gap567 between the two hooks 566 a and 566 b at the relaxed state.

Between the crossing point 562 and the bridge 558, the legs 560 a and560 b provide a grip section 570 a and 570 b, respectively, which may betextured. The illustrative grip sections 570 a and 570 b run parallel toeach other in a relaxed state. When the grip sections 570 a and 570 bare compressed towards each other, the first leg 560 a moves in thedirection indicated by an arrow 572 a while the second leg 560 b movesin the direction indicated by an arrow 572 b. However, because the legs560 a and 560 b cross over each other, the hooks 566A and 566B move awayfrom each other to increase the gap 567. Where the entire or part of thefilament 554 is elastic, such as a spring, the two legs 560 a and 560 bspring back to their relaxed state in response to the compressive forceagainst the grip sections 570 a and 570 b is removed.

A first notch 578 a is located on a first side 576 a of the plugconnector 556. A second notch 578 b is located on a second, oppositeside 576 b. The diameter 581 of the plug connector is greater than thegap 567 between the two hooks 566 a and 566 b at a relaxed state.Therefore, after the hooks 566 a and 566 b engage the notches 578 b and578 a, respectively and the operator removes the compressive force, theywill be locked inside the plug connector 556. The illustrative notches578 a and 578 b remain separated by a barrier 582 in between, but theycan be joined to form a traverse opening (not shown). The illustrativeplug connector 556 also includes a conical section 580 distal to thenotches 578 a and 578 b.

To interconnect the two connectors 552 and 556, the operator compresses,manually or through an instrument, at least one of the grip sections 570a and 570 b towards each other, causing the two distal hooks 566 a and566 b to part and the open loop 568 to expand. Then the operator slidesthe two legs 560 a and 560 b onto the two sides 576 a and 576 b of theplug connector 556 until the hooks 566 a and 566 b enter the notches 578b and 578 a, respectively. Then the operator releases the grip sections570 a and 570 b, and the hooks 566 a and 566 b return from thecompressed state to the relaxed state and converge to each other andproject radically into respectively the notches 578 a and 578 b. Toseparate the two connectors 552 and 556, the operator reverses the abovesteps.

FIG. 63A depicts connectors that can potentially interconnect more thantwo parts of the delivery system, even if only temporarily, during use.This inventive aspect is illustrated with applications involving a guidetube, but are equally applicable to other parts of the delivery system.

In the illustrative embodiment, plug connectors 626 a and 626 b areprovided to interconnect a shaft 600, a guide tube 602, and a slingassembly 604. The shaft 600 can optionally connect with a handle 606,for example, with a proximal shaft end 608 that slidably resides in anaxial lumen in the handle 606. An opposite, distal end 610 of the shaft600 slides into a proximal opening 612 of the guide tube 602 such thatat least part of the shaft 600 slidably resides in an axial lumen 614(FIG. 63B) of the guide tube 602. The illustrative shaft distal end 610includes a tapered distal tip 611. The lumen 614 (FIG. 63B) of the guidetube 602 extends between a proximal opening 612 and a distal opening 616of the guide tube 602 (not shown). The guide tube 602 includes a distalend 617 and a proximal end 619. In one embodiment, the proximal end 619is flared, i.e., having an outer diameter larger than the rest of theguide tube 602. The sling assembly 604 includes two identical free ends:a first end 618 a and a second end 618 b, and a sling 620 at leastpartly enveloped in a sleeve member 622.

Optionally, the two ends 618 a and 618 b of the sling assembly 604 eachinclude a dilator (624 a, 624 b). A first plug connector (626 a, 626 b)is attached to each of the free sling assembly ends 618 a and 618 b, forexample, through pre-associating with the dilators 624 a and 624 b,respectively. The first connector (626 a, 626 b) can be manufactured asan integral piece with the dilator (624 a, 624 b).

FIG. 63C depicts, in a cross-sectional view, the illustrative plugconnector 626 a including a “barbed” distal section 628 and areduced-diameter section 630, for example, a circular notch. The distalsection 628 has a maximum diameter 629 at its base 634. The maximumdiameter 629 is greater than diameter 633 of the reduced-diametersection 630. The distal section 628 tapers radically inward towards adistal end 632 to facilitate insertion into a mating receptacleconnector 640 and forms a shoulder 634 for hindering movement in theproximal direction as indicated by an arrow 633 by the distal section628. The shoulder 634 may be formed at any angle 636 less than or equalto about 90° relative to a longitudinal axis of the connector 626 a.Illustratively, the angle 636 is depicted as being 90°. The distal end632 of the distal section 628 includes an opening 638 that is shaped andsized to fit at least a portion of the distal tip 611 of the shaft 600.The connector 626 a may be made of any suitable material, for example,plastics, rubber, or a metal, through processes known in the art, forexample, tip molding.

Referring back to FIG. 63A, the distal 617 and/or proximal 619 ends ofthe guide tube 602 can include a second receptacle connector 640. FIGS.63B and 63D depict, in cross-sectional views, the second receptacleconnector 640 including an optional annular stepped-up portion 642narrowing the lumen 614. The resultant lumen space 614 a between theprotuberance 642 is narrower than the maximum diameter 629 in the distalsection 628 of the first connector 626 a (FIG. 63C). The illustrativestepped-up portion 642 is disposed at the opening 612 or 616 of thelumen 614. The internal protuberance 642 may be manufactured as anintegral part of the receptacle connector 640 or the guide tube 602.

FIG. 64 depicts the first plug connector 626 a interconnecting with boththe distal tip 611 of the shaft 600 and the second receptacle connector640. There are a few ways to accomplish this connection. In a firstexample, the tip 611 of the shaft 600 is first inserted into the distalopening 638 in the first connector 626 a when the tip 611 is extendedoutside the distal opening 616 of the guide tube 602. This insertionstep can be accomplished by either moving the first connector 626 a orthe shaft 600 or both. Then, the operator can push the base part of thefirst connector 626 a, for example, the dilator 624 a, under theguidance of the interconnected shaft tip 611 into the distal opening 616of the guide tube 602. Optionally, to facilitate the insertion of thefirst connector 626 a past the internal protuberance 642, either or boththe distal section 628 of the first connector 626 a or the secondconnector 640 can include longitudinal slots as described in connectionwith FIGS. 45 and 46A. After the first connector 626 a enters the distalopening 616 of the guide tube 602 and passes the protuberance 642, theprotuberance 642 encircles the reduced-diameter section 630 of the firstconnector 626 a and locks it in.

In a second example, the shaft tip 611 is inserted into and retained inthe distal opening 638 of the first connector 626 a, for example, if thedistal opening 638's lumenal diameter is no larger than the thickestpoint on the shaft tip 611 such that the shaft tip 611 gets stuck onceinserted into the distal opening 638. In alternative embodiments, any ofthe connector pairs or their associating features described in thisspecification can be utilized to retain or lock the connection betweenthe shaft tip 611 and the distal opening 638 of the first connector 626a once the connection is made. Then, the operator withdraws the shafttip 611 back into the lumen 614, guiding the first connector 626 a intothe distal opening 616 of the second connector 640. Of course, theoperator can interconnect the first connector 626 a with the secondconnector 640 by holding fast the second connector 640 in one hand andinsert the first connector 626 a through the distal opening 616 in thesecond connector 640. The rest of the steps are the same as describedimmediately above.

With the second connector 640 disposed in the proximal end 619 of theguide tube 602 and using one of the above described methods, the firstconnector 626 a can be interconnected with the second connector 640 whenthe shaft 600 is withdrawn out of the guide tube 602. It is alsocontemplated by the invention that the shoulder 634 can form a barb 631that is sufficient to interfit and retain itself inside the secondconnector 640 even if the second connector 640 does not have theinternal protuberance 642, but instead a smooth inner wall. In thatcase, the shoulder 634 preferably has a cross-sectional dimension (forexample, a diameter in a circular cross section) at least as large asthe cross-sectional dimension of at least the narrowest part of thelumen 614 in the guide tube 602, so that the barb 631 engages thelumenal wall in the guide tube 602 to impede disconnection.

FIG. 65A depicts a sheath 650 that can be used in combination with anyconnector pair, including the connectors described in this application.The sheath 650 slidably encloses a part in the delivery system, forexample, at least a portion of a shaft 652. The sheath 650 can bedisposed on other parts of the delivery system, such as the slingassembly. The sheath is preferably colored, for example, blue, so that amedical operator can distinguish it from surrounding tissue during acystoscopy. The sheath 650 may be made, for example, of medical-gradeplastics, silicone rubber, polymer or similar materials. In analternative embodiment, the sheath 650 is made of a metal. The sheath650 has a distal portion 654 and, optionally, a proximal “hub” 656 withan enlarged outer diameter. An annular collar 655 is, optionally,disposed in the distal portion 654 of the sheath 650. In one embodiment,the surface of the annular collar 655 is textured. The shaft 652 has adistal portion 657 and a proximal portion 658 that is associated with ahandle 660. The sheath 650 mayor may not be operatively connected to thehandle 650 for slideable actuation along the shaft 652. Additionally,the length of the sheath 650 can range from less than about two inchesto almost as long as the shaft 652.

In one embodiment, the stopper 662 extends from the handle 660 in thedirection of the sheath 650. A stopper 662, when deployed, stops thesheath 650 from moving in the proximal direction, toward the handle 660to maintain the distal portion 654 of the sheath 650 over the distalportion 657 of the shaft 652 (the “advanced position” of the sheath650). When the stopper 662 is not deployed, the sheath 650 can slide inthe proximal direction into a withdrawn position, for example, until thehub 656 meets the handle 660. An example of a suitable stopper 662includes a spring lever that remains deployed unless compressed.

To advance the sheath 650 to its advanced position, the operator canmanually push the proximal hub 656 in the distal direction.Alternatively, if there is a pusher assembly such as the one describedin connection with FIGS. 3-6, the operator can actuate the pusherassembly to advance the sheath 650. Further, if the operator is pullingthe sheathed shaft 652 in the proximal direction through a tunnel in thetissue, the surrounding tissue will push and squeeze the sheath oroptionally the annular collar 655 at the distal portion 654 of thesheath 650 such that the sheath 650 advances in relation to the shaft652.

Referring now to FIG. 65B, when the sheath 650 is at the retractedposition. The retracted sheath 650 exposes a slotted connector at thedistal shaft portion 657. In one embodiment, the connector is areceptacle connector 666 similar to receptacle connectors previouslydescribed in connection with FIGS. 22A-35. In the illustrativeembodiment, the loop connector 664 is similar to loop connectors alreadydescribed, such as those described in connection with FIGS. 22A-25, 33,34, and 36A-38.

Once the loop 664 and receptacle 666 connectors are interfitted, thesheath 650 is axially actuated to the position shown in FIG. 65A toshield at least the receptacle connector 666. The stopper 662 isdeployed to lock the sheath 650 at the advanced position. An otherwiseexposed slot 668 shown in FIG. 65B can catch tissue during subsequentmaneuver through patient tissue. In another embodiment, at the advancedposition, the distal portion 654 of the sheath 650 abuts the dilator 680to shield not only the receptacle connector 666 but also theinterconnected loop connector 664 and a portion of the dilator 680.Accordingly, the interconnected shaft-dilator complex may have a smoothtransition and a constant diameter, and the sheath 650 also serves alocking and retention function. To separate the connectors 664 and 666,the operator can deactivate the stopper 662 (FIG. 65A), and pull theproximal hub 656 towards the handle 660 to expose and separate theconnectors.

Further, because the sleeve end 684 surrounds (e.g., through heatbonding) the proximal portion 686 of the dilator 680, the proximalportion 686, especially the back edge 688, will not be caught in thetissue during sling delivery or adjustment, for example, when theoperator has to pull the sling assembly 678 back through a tunnel toreposition it. The sling assembly 678 needs to be repositioned when thebladder has been punctured during the delivery process. To aid thedetection of bladder puncture under a cystoscope, the sleeve assembly678, for example, the sleeve 682 or the mesh sling (not shown), may becolored (e.g., blue). In use, an operator can delay any cystoscopy untilone or both sleeve ends of the sling assembly 678 are in one or twotissue tunnels to check for visual signs of the colored sling assemblyand/or other colored components of the delivery system such as the shaft652, the sheath 650, or a guide tube.

FIG. 66A depicts a sheath 671 that can be used as an alternative to thesheath 650. In the illustrative embodiment, the sheath 671 slidably fitsover the distal portion 657 of the shaft 652. The slotted receptacleconnector 666 is disposed at the shaft distal portion 657 as previouslydescribed with respect to FIG. 658. The loop connector 664 interconnectswith the receptacle connector 666. An optional stopper 673 is disposedadjacent the shaft distal portion 657 to prevent the sheath 671 totravel past it over the shaft 652. The illustrated stopper 673 is anannular ring. In another embodiment, the stopper 673 is a stepped upportion of the shaft 652 that can extend proximally to any length.Alternatively, the sheath 671 can be friction fitted onto the shaftdistal portion 657 such that no stopper is 673 needed and the sheath 671will substantially maintain its position relative to the shaft 652.There are various ways to achieve a frictional fit. For example, thesheath 671 can have an inner diameter that matches or is slightly lessthan the outer diameter of the shaft distal portion 657. For example,the sheath 671 can have an axial opening and an inner diameter slightlyless than the shaft outer diameter so that the sheath 671 can be snappedonto the shaft distal portion 657 through the opening. Alternatively,the sheath 671 can be heat shrunk over the shaft distal portion 657.

The illustrative sheath 671 is of a length that covers the joint lengthbetween the receptacle connector 666 and the loop connector 664 when theconnectors are interconnected. In another embodiment, the sheath 671 isof a length that only covers the connector slot 668. In one embodiment,the sheath 671 is less than about one inch. The operator, afterinterconnecting the two connectors 664 and 666, can manually slide thesheath 671 over the connectors to lock the interconnection. In analternative embodiment, the sheath 671 is located on the sleeveassembly, for example, the dilator 680, and can also be manuallyactuated to slidably shield the slotted receptacle connector 666, orboth connectors 666 and 664.

FIG. 66B depicts a partial cross sectional view of another alternativesheath 681 that covers at least part of the slot 668 in the receptacleconnector 666. The illustrative sheath 681 abuts a stepped-up portion683 of the shaft 652. A distal portion 681 a of the sheath 681 covers aportion of an entry notch 670 of the connector slot 668. In use, a loop676 of a mating loop connector 664 has to deflect the sheath distalportion 681 a to enter the entry notch 670. The illustrative sheath 681is flexible and returns to the overlaying position afterwards and locksthe mating loop 676 inside the receptacle slot 668. The illustratedsheath 681 can be deflected to release the mating loop 676. In oneembodiment, the sheath 681 is heat shrunk plastics such aspolytetrafluoroethylene (PTFE) or tetrafluoroethylene (TFE).

FIGS. 67A and 67B depict an alternative sheath 690 that automaticallylocks in the connection between two connectors, even before theinterconnected devices travel through the patient's tissue. The sheath690 slidably encloses at least a portion of in the delivery system, forexample, at least a portion of the shaft 652. The shaft 652 has thereceptacle connector, for example, a receptacle connector 666, at thedistal portion 657 of the shaft 652. The receptacle connector 666includes a slot 668 that, in one embodiment, includes an entry notch 670and a retention slot 672 connected at the bottom 671 of the entry notch670, forming an “L.”

The sheath 690 may share many features with the sheath embodiment 650described immediately above. In addition, the sheath 690 has a slot 692that extends from the periphery towards the long axis of the sheath 690.The slot 692 in the sheath 690 substantially matches, in size and shape,the entry notch 670 of the L-slot 668 in the receptacle connector 666.

The plug connector, for example, the loop connector 664 has a loop 676and is attached to the dilator 680 of the sling assembly 678. The loop676 may be formed from a suturing material. Alternatively, the loop 676may be formed from a semiflexible, shape-retaining material. Tointerconnect the loop connector 664 with the receptacle connector 666,the operator matches up the slot 692 in the sheath 690 with the entrynotch 670 in the receptacle connector 666, and hooks the loop 676 of theloop connector 664 into the slot 692/entry notch 670. The operator thensinks the loop 676 into the bottom 671 of the entry notch 670 of thereceptacle connector 666.

Specifically referring to FIG. 67B, after the loop 676 reaches thebottom 671 of the entry notch 670 of the receptacle connector 666, theoperator can pull the dilator 680 in a direction indicated by an arrow694 such that the loop 676 of the loop connector 664 slides down theretention slot 672 of the receptacle connector 666. Alternatively, ifthe loop 676 is an adjustable and lockable loop as described inconnection with FIGS. 36A-38, the operator can tighten and lock the loop676 against the distal portion 657 of the shaft 652, which wouldsimilarly cause the loop 676 of the loop connector 664 to slide down theretention slot 672 of the receptacle connector 666. Because the loop 676is still hooked in the sheath slot 692, the sheath 690 advances in thedirection indicated by the arrow 694 along with the loop 676 of the loopconnector 664. Now that the sheath slot 692 is no longer matched up withthe entry notch 670 in the receptacle connector 666, the sheath 690locks the loop 676 inside the retention slot 672. To unlock the twoconnectors 664 and 666, the operator can pull the sheath 690 in thedirection opposite to the arrow 694, or, in the case of a adjustable andlockable loop 676, unlocks and lengthens the loop 676, until the sheathslot 692 is matched up with the entry notch 670 in the receptacleconnector 666.

FIG. 68 illustrates, in a cross-sectional view, connectors withapplications in associating an implant to the side of one or more guidetubes. A delivery device 700 includes a shaft 702 and a guide tube 704.The shaft 702 has a distal portion 706 and a proximal portion 708. Theshaft 702 may be straight or curved, and may have features describedelsewhere in this application. The proximal end 708 of the shaft 702connects to the handle 710. The guide tube 704 may function as a dilatortube. In one embodiment, the guide tube 704 is separate from and notattached to, the handle 710. However other embodiments, the guide tube704 attaches either reversibly or permanently the handle 710 through anactuator, such as those described in connection with FIGS. 7A and 78.

The guide tube 704, according to an illustrative embodiment of theinvention, is elongated and includes a wall 712. The wall 712 has aproximal end 714, a distal end 716. A lumen 718 axially extends betweena distal opening 722 and a proximal opening 720. According to onefeature of the illustrative embodiment, the lumen 718 slidably receivesthe shaft 702 through a proximal opening 720. In alternativeembodiments, the guide tube 704 may instead include port 721 in the sideof the wall 712 for receiving the shaft 702. The illustrative guide tube704 is of a length such that when the shaft 702 resides inside the lumen718, the distal tip 707 of the shaft 702 extends outside the distalopening 722. According to another feature, the proximal end 714 of thedilator tube 704 flares so that the outside diameter of the proximal end714 is wider than the outside diameter of the remainder of the dilatortube 704. However, in alternative embodiments the outside diameter ofthe dilator tube 704 is substantially uniform from the proximal end 714to the distal end 716.

According to one feature of the invention, the guide tube 704 has first724 a and second 724 b connectors axially separated along it. Preferablythe first connector 724 a is located at the distal end 716 and thesecond connector 724 b is located at the proximal end 714. In oneembodiment, both the first and second connectors 724 a and 724 b includeside openings or sockets and may extend into the lumen 718. In anotherembodiment, the first and second connectors 724 a and 724 b aredepressions or indentations in the side of the guide tube 704 and do notextend into the lumen 718 of the guide tube 704. The first and secondconnectors 724 a and 724 b may be any suitable connectors, includingthose described elsewhere in this application. The first and secondconnectors 724 a and 724 b, in an optional feature, align with eachother radically along guide tube 704. In another embodiments (notshown), the first connector 724 a and second 724 b may be radicallyoffset from each others.

With continued reference to FIG. 68, an implant, for example, a slingassembly 726 is shown with a mesh sling 728 at least partly enveloped inan optional sleeve member 730. The sling assembly 726 attaches to theguide tube 704 via connectors 732 a and 732 b, which interfit withconnectors 724 a and 724 b, respectively.

Referring now FIG. 69, an assembled delivery system includes thedelivery device 700 guide tube 704 and sling assembly 726. As shown,with the sling assembly 726 and guide tube 704 interconnected asdescribed above, the guide tube 704 slidably interfitted proximal end720 first over the shaft 702, to expose the distal tip 707 of the shaft702. In an alternative embodiment (not shown), the guide tube 704 islonger than the shaft 702. In such an embodiment, the guide tube 704 canslidably retract to expose the distal tip 707 of the shaft 702 during atissue piercing procedure. For example, the guide tube 704 can slidablyretract into the handle 710. In another alternative embodiment, withoutregard to their comparative lengths, the shaft tip 707 is exposed by anactuator that is either operatively associated with the guide tube 704or the shaft 702, an which can actuate the shaft 702 or the guide tube704 axially, related to the other. Examples, of such embodiment aredescribed in connection with FIGS. 7A-8B.

FIG. 70 depicts a side view of a delivery system in which the slingassembly 726 is attached at the connector 732 a to a proximal end 746 aof the first guide tube 740 a and at the connector 732 b to a proximalend 746 b of a second guide tube 740 b. The second guide tube 740 bslidably interfits over the shaft 702 via proximal opening 750. Thefirst guide tube 740 a slidably interfits over the second guide tube 740b via a proximal opening 744. The distal tip 707 of the shaft 702extends through a distal opening 742 of the first guide tube 740 a. Bothillustrative proximal tube ends 746 a and 746 b are flared. Each of theguide tubes 740 a and 740 b has a connector 748 a and 748 b for matinginterconnection with the sling assembly connectors 732 a and 732 b,respectively.

FIG. 71 depicts an alternative embodiment where the sling assembly 726is interconnected with guide tubes 752 a and 752 b having side ports 754a and 754 b through which the shaft 702 is inserted. More particularly,the shaft 702 is passed through the guide tube 752 b via the side port754 b, and the guide tube 752 a slidably interfits over the guide tube752 b via the side port 754 a. Similar to the guide tubes 740 a and 740b depicted in FIG. 70, each of the guide tubes 752 a and 752 b has theconnector 748 a and 748 b for mating interconnection with the slingassembly connectors 732 a and 732 b, respectively.

FIG. 72 depicts a sling delivery system 731 where the sling assembly 103is attached to a guide tube 735 a, the guide tube 735 a slidablyinterfits over the shaft 14, and the pusher assembly 30 facilitates theremoval of the guide tube 735 a from the delivery shaft 14. The slingdelivery system 731 includes at least one delivery device 10, the pusherassembly 30, the sling assembly 103, and two guide tubes 735 a and 735b. The delivery device 10 is of the general type described above inFIGS. 1 and 2, and includes the handle 12, and the shaft 14 fixedlydisposed at its proximal end 22 within the handle 12 and extending awayfrom the handle 12.

The shaft 14 includes a first straight section 743 a, a curved section745, and a second straight section 743 b. The first straight shaftsection 743 a attaches to and extends distally from a distal end 16 ofthe handle 12. The curved shaft section 745 extends distally from thefirst straight section 743 a. The second straight section 743 b extendsdistally from the curved section 745, and terminates at a conical distaltip 26.

The pusher assembly 30, described above with respect to FIGS. 3-6,includes the pusher tube 31 slideable fitted over a portion of the firststraight shaft section 743. Both the illustrative shaft 14 and theillustrative pusher assembly 103 are formed of surgical grade stainlesssteel, and excluding the conical tip 26, have a constant diameter alongtheir respective lengths.

The illustrative sling assembly 103 is of the type described above withrespect to FIG. 21. The sleeve ends 108 a and 108 b connect to firstends 733 a and 733 b of guide tubes 735 a and 735 b, respectively. Theillustrative sleeve ends 108 a and 108 b are heat bonded to the firsttube ends 733 a and 733 b. The illustrative guide tubes 735 a and 735 beach include a first opening 737 a or 737 b, a second opening 739 a or739 b and a lumen 741 extending there between. The second tube ends 747a or 747 b includes a tapered section 749 a or 749 b, respectively, thatsubstantially conforms to part of the conical shaft tip 26.

Each of the two guide tubes 735 a and 735 b slidably fits over theconical shaft tip 26 and along the length of the shaft 14, one at atime, to abut the pusher assembly 30. Each illustrative guide tube 735 aor 735 b is a blue, flexible polymer tube. When the pusher assembly 30is retracted and the first tube end 733 a abuts the pusher assembly 30,the conical shaft tip 26 extends beyond the distal tube end 747 a or 747b, and can be used for tissue piercing or tunneling. When the operatorpushes the pusher 30 into the advanced position, the second tube end 747a or 747 b moves distal to the conical shaft tip 26 and becomesaccessible for removal from the shaft 14. During removal, the medicaloperator grasps the tube end 747 a or 747 b, either by hand or usingforceps and pulls in a proximal direction on the delivery device 10.

IV. Exemplary Procedures

Described below are various illustrative methods for delivering animplant, such as a sling or its assembly, to an anatomical site in thebody of a mammalian patient. The illustrative methods includesuprapubic, prepubic, trans-obtruator and transvaginal approaches.

FIGS. 73A-73E depict steps in an illustrative suprapubic-to-vaginalapproach (the “suprapubic approach”) to delivering a sling to amidurethral location or other suburethral tissue. Specifically referringto FIG. 73A, a delivery device 760 includes a shaft 762 attached at aproximal end 768 to a handle 764. A first optional guide tube 766slidably interfits over a distal end 770 of the shaft 762 via a proximalopening 774. Interfitted as such, a conical tip 772 at a distal end 770of the shaft 762 extends through a distal opening 776 in the guide tube766. The shaft 762 may be curved or straight or include both curved andstraight sections, and can be any of the various embodiments describedin this application. The proximal end 775 of the guide tube 766 may ormay not be operatively connected to the handle 764. The delivery device760 may further include a pusher assembly, for example, as described inconnection with FIGS. 3-6, for activating the guide tube 766 off theshaft 762. In the illustrated embodiment, the proximal end 775 of theguide tube 766 is depicted as being flared. However, this need not bethe case. Either or both of the distal end 770 of the shaft 762 and adistal end 777 of the guide tube 766 include a first connector 779marked in general with a circle, which can be any suitable connector,such as and without limitation, any of the connectors described hereinor in a disclosure incorporated by reference.

The procedure of FIGS. 73A-73C employ a sling assembly 788. The slingassembly 788 may be any suitable sling assembly, such as and withoutlimitation, any of the sling assemblies disclosed herein or indisclosures incorporated by reference. The particular sling assembly 788includes a mesh sling 790, partially enclosed by a sleeve 792. A tab orfastener 794 attaches to the sleeve 792 at an intermediate location toaid in sling placement and in removal of the sleeve 792 from the body ofthe patient. The sling assembly 788 at end 796 a includes or attaches toa connector 798 a. Similarly, the sling assembly at end 796 b attachesto or includes a connector 798 b. The connectors 798 a and 798 b may beany suitable connector, such as and without limitation, any connectordescribed herein or in a disclosure incorporated by reference.

In use, the medical operator grasps the proximal end 768 of the shaft762 or the handle 764, and introduces the shaft 762, optionally sheathedin the guide tube 766, into a patient through a puncture 778 in theabdominal skin 780. The delivery device 760 tunnels through theabdominal wall, abdominal fascia, and rectus fascia until the shaft tip772 emerges through a second puncture 782 in the vaginal wall 784,creating a first tunnel 785 between the abdominal puncture 778 and thevaginal puncture 782 on one side of the urethra 786.

To make sure that the bladder (not shown) is not accidentally puncturedby the advance of the delivery device 760, a cystoscopy may be performedat any point during the surgical procedure to look inside the urethra786 and the bladder. In a preferred embodiment, the guide tube 766and/or the shaft 762 and/or the sleeve 792 and/or the sling 790 exhibitsa visible or discernable optical property, for example, by being blue orgreen in color, to distinguish it from the tissue and fluid in theurethra and the bladder. In the embodiment where the guide tube 766includes apertures as described in connection with FIGS. 10A, 10B and11, the operator can skip the cystoscopy step and instead rely on beingalerted by bodily fluid from the bladder, such as urine or blood,flowing out of one of the apertures, in case of inadvertent puncture ofthe bladder. Further, if the shaft 762 is sheathed by the guide tube766, the guide tube 766 may be placed and cystoscopy delayed untilanother guide tube is placed on the contralateral side, and only onecystoscopy needs to be performed.

Referring also to FIG. 73B, in the embodiment where the delivery device760 does not include a guide tube, the operator interconnects the shaftconnector 779 with the sling assembly end connector 798 a, and withdrawsthe shaft 762 back into the first tunnel 785 and out of the abdominalpuncture 778 until the sling assembly end 796 a emerges from theabdominal puncture 778. The operator then separates the connector 779from the connector 798 a.

The operator then repeats the above steps on the contralateral side ofthe urethra 786 and creates a second tunnel 800 with the same shaft 762or a second shaft. As mentioned above, if a second shaft is used, theoperator can leave the first shaft 762 in the first tunnel 785 and waituntil this point to conduct a single cystoscopy to confirm that neithershaft has punctured the bladder. Assuming the operator is using the sameshaft 762, however, the operator interconnects the shaft connector 779to the sling assembly connector 798 a. The operator then withdraws andpulls the shaft 762, along with the interconnected sling assembly end796 b, through the second tunnel 800 until the end 796 b emerges on thecontralateral side. The operator separates the connector 779 from theconnector 798 a or dissociates the connector 798 b from the slingassembly 788, for example, by cutting.

Referring specifically to FIG. 73C, in the optional embodiment where thedelivery device 760 includes a guide tube 766, after the distal end 777of the guide tube 766 becomes interconnected with the sling assembly end796 a through the connector 779 and the connector 798, the operatorwithdraws the shaft back from the first tunnel 785 and out of theabdominal puncture 778, leaving the guide tube 766 inside the firsttunnel 785. Subsequent to confirming through cystoscopy that the bladderhas not been punctured or perforated, the operator pulls the guide tube766 out of the abdominal puncture 778 through the first tunnel 785,along with the sling assembly end 796 a. Alternatively, the operator canwait until a second guide tube is placed similarly on the contralateralside before pulling the first guide tube 766 out of the first tunnel785, allowing a single cystoscopy to be performed. The proximal end 775of the first guide tube 766 may be held in place, if necessary, with ahand or a medical instrument for example, a clamp. However, in theembodiment where the proximal end 775 of the first guide tube 766 isflared, i.e., has a larger outer diameter than rest of the guide tube766, the flaring on the guide tube 766 helps to prevent the guide tube766 from slipping into the first tunnel 785.

The operator repeats the above steps on the contralateral side of theurethra 786 and creates a second tunnel 800 with the delivery device760, substituting the guide tube 766 with a guide tube 766′ having aconnector 779′ at its distal end 802. The guide tube 766′ is preferablyidentical to the guide tube 766. After the distal end 802 of the guidetube 766′ emerges from a second vaginal puncture 782′ in the vaginalwall 784, the operator interconnects the connector 779′ attached to theguide tube 766′ with the sling assembly connector 798 b. The operatorthen pulls the guide tube 766′ by its proximal end 775′ through thesecond tunnel 800 until the end 796 b of the sling assembly 788 emergesout of the abdominal incision through the second tunnel 800. Afterperforming cystoscopy in series with the placement of each guide tube,or a single cystoscopy after both tubes are placed, to make sure thatneither guide tube 766 or 766′ has punctured the bladder, the operatorseparates the guide tube 766 from the sling end 796 a and separates theguide tube 766′ from the sling assembly end 796 b. If a puncture isfound in either the bladder or the urethra 786, the operator may removeeither or both the guide tubes 766 and 766′ and repeat the above stepsto reinsert the guide tube(s).

Referring now to FIG. 73D, regardless of whether guide tubes (FIG. 73C)or only shafts (FIG. 73B) are used, the operator adjusts the positionand tension in the sling assembly 788 to finish the delivery process.The operator may also use a medical instrument, for example, forceps, toadjust the sling assembly 788. Subsequently, the operator removes thesleeve 792, and other components of the sling assembly 788 such as theconnectors 798 a and 798 b if still attached, from the patient. Forexample, the operator may cut the fastener tab 794 to separate thesleeve 792 into two sleeve segments 792 a and 792 b. Then the operatorcan pull the sleeve segments 792 a and 792 b by their ends 796 a and 796b out the first 785 and second 800 tunnels, respectively. Only the meshsling 790 is left within the patient body in the periurethral tissue,for example, underneath the midurethra 786 or the bladder neck, and maybe trimmed at each end to just below the skin of the abdomen.

Referring now to FIG. 73E, after the mesh sling 790 has been deliveredand placed in the periurethral tissue, the abdominal and vaginal woundsare sutured if needed. The implanted sling 790 elevates part of thevaginal wall 784 and its surrounding tissue, as a solution to treaturinary incontinence.

The above methodology may be employed for any abdominal entry approach,such as, for example, a prepubic approach.

In the above-described suprapubic and prepubic approaches, specificadvantage may be achieved where a shaft 762 of the type described inconnection with FIGS. 13A, 13B, and 14-16 is used. That advantage is nowdescribed in the context of tunneling from the abdominal puncture to thevaginal puncture using the shaft 80. The other steps in this embodimentof the approach are similar to the ones described in connection with theshaft 762 and will not be repeated.

FIG. 74 illustrates, through a schematic side view of the female pelvicarea, an illustrative embodiment of the invention casing the deliverydevice described with respect to FIG. 15. The illustrative shaft 80 isattached to the handle 81. The shaft 80 includes at least two arcs 84and 85. The shaft 80 also optionally includes an angled distal end 91 b.The operator grasps the handle 81 and introduces the shaft 80 throughthe abdominal skin 780, abdominal wall, abdominal fascia, and rectusfascia in the suprapubic region of the pubic area until the distal end91 of the shaft 80 emerges through the incision on one side of thevaginal wall 784. The arcs 84 and 85 enable the operator to pass throughthe suprapubic region to the vagina and navigate around internal organsmore easily than a single arc/curve configuration. The shaft 80 isinserted at a first position 810 (phantom line) through the abdominalskin 780, abdominal wall, abdominal fascia, to the suprapubic region ofthe pubic area, near the pubic bone 812. In a preferred embodiment, thedistal tip 91 b is pointed toward the pubic bone 812, and away fromother organs such as the bladder 811 to prevent puncturing them.

The operator moves the shaft 80 from the first position 810 to a secondposition 814 in a direction indicated by a first arrow 816. The arcs 80and 82 enable the operator to move the distal tip 91 of the shaft 80along the contour of the pubic bone 812. From the second position 814,the operator pushes the shaft 80 in the direction indicated by a secondarrow 818 and the shaft 80 passes adjacent the posterior side 820 of thepubic bone 812 on its way towards the vagina 815.

With continued reference to FIG. 74, during the procedure, the operatordirects the angled distal end 91 along the posterior side 820 of thepubic bone 812 to avoid accidental perforation of other organs whileadvancing towards the target area. The plurality of arcs in the shaft 80provides ergonomic benefits. For example, the first arc 80 provides themedical operator with clearance between the medical operator's hand andthe patient's body while allowing the operator to exert sufficient forceonto the shaft 80 to advance the shaft 80 in its intended course, forexample, from the second position 814 in the direction indicated by thesecond arrow 818 during the above-described embodiment of suprapubicapproach. The contour of the shaft 80 and the angle of the distal end 91of the shaft 80 work together to lessen the risk of injuring organsincluding the urinary bladder 811, which could otherwise be harmedduring the surgical procedure. The operator may perform cystoscopy todetermine if the bladder had been perforated.

Referring now to FIG. 75, the operator may opt for the pre-pubicapproach, which tunnels between the abdominal skin 780 and the anteriorside 821 of the pubic bones 812 to eliminate any chance of perforatingthe bladder 811. In an illustrative embodiment, the delivery devicedescribed with respect to FIG. 15 having the shaft 80 with at least twoarcs 84 and 85 is again used as an example to illustrate the principleof this approach, while shafts of other shapes and structures may beused for the pre-pubic approach as well. The medical operator grasps thehandle 81 and introduces the shaft 80 through a puncture 822 in theabdominal skin 780, with the angled distal end 91 b first, into theabdominal fascia, and through the pre-pubic region of the pubic areauntil the distal end 91 b of the shaft 80 emerges through an incision onthe vagina wall 826. Specifically, the shaft 80 passes along theanterior surface 821 of the pubic bone 812, for example, from a firstposition 826 (shown in phantom) to a second position 828, while theangled distal end 91 b of the shaft 80 follows the contour of theanterior surface 821 of the pubic bone 812. Because the bladder 811 andother vital organs are posterior to the pubic bone 812, the operatoreliminates the risk of inadvertent perforation of these organs bypassing through the pre-pubic region to the vagina 815. Similar to whatis described in connection with the suprapubic approach, the pluralityof arcs 84 and 85 in the shaft 80 provides ergonomic benefits for theprocedure. In the pre-pubic-to-vaginal method, the operator does notneed to conduct any cystoscopy to confirm the integrity of the bladderand the urethra.

After a first tunnel from the abdominal skin 780 to the vaginal wall 826is created through the above steps, the remaining aspects of thepre-pubic approach is the same as the supra-pubic approach describedabove. The prepubic approach can also be performed with two needles withor without guide tubes.

FIGS. 76A and 76B depict steps of a transvaginal approach according toan illustrative embodiment of the invention. Specifically, referring toFIG. 76A, a delivery device 840 includes a shaft 842 attached at aproximal end to a handle 843.

The shaft 842 has a distal end 846 with a distal tip 848. The shaft 842may be curved or straight or include both curved and straight sections.As in the case of the shaft 762 (FIGS. 73A and 73B), the shaft 842 canbe any suitable shaft, including without limitation any of those shaftsdisclosed herein or in disclosures incorporated by reference. The distalend 846 of the shaft 842 includes a connector 850, marked in generalwith a circle. The connector 850 can be any suitable connector,including without limitation, any of those disclosed herein or indisclosures incorporated by reference.

As in the case of the suprapubic and prepubic approaches of FIGS.73A-73E, the delivery device 840 may be any suitable delivery device,including without limitation, any of those delivery devices disclosedherein or in the disclosures incorporated by reference.

As in the case of the procedures of FIGS. 73A-73E, the procedures ofFIGS. 76A and 76B employ the sling assembly 788. In use, the medicaloperator interfits or interconnects the sling assembly end 796 a to theshaft 842, for example, by way of the shaft connector 850 and slingassembly connector 798 a. Alternatively, in embodiments where the slingassembly 788 attaches to dilator tubes, such as the dilator tubes 735 aand 735 b of FIG. 72, the operator slidably interfits the shaft 842through the dilator tube 735 a or 735 b, without any interconnection.Next, the operator grasps the proximal end 844 of the shaft 842 or thehandle 843, and introduces the shaft 842 tip 848 first, into a puncture854 in the vaginal wall 784 on one side of the urethra. The operator,using the shaft 842, tunnels transvaginally through the rectus fascia,abdominal fascia, and abdominal wall in the region of the pubic tubercleuntil the distal end 846 of the shaft 842 emerges through a puncture 856on one side of the abdominal skin 780, creating a first tunnel 858between the vaginal puncture 854 and the abdominal puncture 856. Similarto the suprapubic and prepubic approaches, the shaft 842 (where adilator tube is not employed) or the sleeve 792 preferably exhibits avisibly discernable optical property such that the shaft 842 can bedistinguished from the surrounding tissue during a cystoscopy.

The operator then separates the shaft connector 850 from the slingassembly connector 798 a. The operator keeps the sling assembly end 796a from slipping back into the abdominal puncture 856 using, for example,a clamp. The operator proceeds to create a second tunnel 860 on thecontralateral side of the urethra 786 by repeating the above steps withthe sling assembly end 796 b. The same shaft 842 or a second shaft maybe used.

After both ends 796 a and 796 b have emerged on the abdominal side, andthe cystoscopy confirms that the bladder and the urethra 786 have notbeen perforated, the operator then adjusts the position and tension inthe sling assembly 788 to finish the delivery and implanting process asdescribed earlier in connection with the suprapubic approach.

Referring now to FIG. 77, in another illustrative transvaginal approach,a distal end 868 of a guide tube 866 attaches to an implant such as asling assembly. This approach is essentially the same as the approach ofFIGS. 76A and 76B except that the interconnection is between the slingassembly and the distal end 868 of the guide tube 866. An advantage ofthis embodiment is that two guide tubes may be placed, one on each sideof the urethra, using a single shaft. Once both guide tubes are placed asingle cystoscopy may be performed to verify placement. A pusherassembly such as the pusher assembly 30 of FIG. 72 may be employed tofacilitate removal of the dilator tubes from the shaft 864.

Referring now to FIG. 78A, in another illustrative transvaginalapproach, a proximal end 880 of a guide tube 876 attaches to the slingassembly end 796 a. The interconnection between the sling assemblyconnector 798 a and the proximal end connector 882 on the guide tube 876may be made prior to insertion of the guide tube 876 into the body, asshown in FIG. 72, or subsequent to guide tube insertion, as shown inFIG. 78A. The delivery device 870 may also include a pusher assemblysuch as that shown in FIG. 72, and as described in connection with FIGS.3-6, for axially actuating the guide tube 876 off the shaft 842. Oneexample of the guide tube 876 is described in connection with FIGS.63A-63D and 64. Another exemplary guide tube is described with respectto FIG. 72 where a proximal end of the guide tube is interconnected, forexample, through heat bonding, with an end of a sling assembly. As inthe embodiments, the distal tip 848 of the shaft 842 extends outside thedistal end 878 of the guide tube 876 for piercing through the tissue.The operator, using the shaft 842 sheathed in the guide tube 876,tunnels transvaginally to create the first tunnel 858 as described inconnection with FIGS. 76A and 76B.

Referring also to FIG. 78B, if a pusher assembly such as the pusherassembly 30 with respect to FIG. 72 is employed, the operator actuatesin the distal direction to edge enough of the guide tube 876 off theshaft 842 so that the operator can grasp the distal end 878 of the guidetube 876 by hand or with the assistance of an instrument. Once the guidetube 876 is grasped, the operator withdraws the remainder of the shaft842 from the first tunnel 858 by pulling it out of the vaginal puncture854. With the guide tube 876 remaining in the tunnel 858, the operatorcan clamp its distal end 878 to stop the tip 878 from slipping back intothe tunnel 858. The operator can perform a cystoscopy and remove theguide tube 876 at this point (as shown in FIG. 78B) or repeats the abovesteps on the contralateral side of the urethra 786 and creates a secondtunnel from the vaginal wall 784 to the abdominal skin 780, substitutingthe first guide tube 876 with a second substantially identical guidetube. The operator can use the same shaft 842 or a different one. If twoshafts are used, cystoscopy may be done in series, or both tubes may beinserted on both sides before single cystoscopy is performed. Once thecontralateral guide tube is placed and placement is verified, both guidetubes can be pulled through the respective vaginal incisions to positionthe sling assembly 788. Then the guide tubes can be separated from thesling assembly 788 by, for example, cutting.

FIGS. 79A and 79B illustrate another transvaginal approach, in whichboth distal and proximal ends of the guide tube 704 are attached to thesling assembly 726. The delivery system 700 is described in connectionwith FIGS. 68 and 69, and includes the shaft 702 and the guide tube 704.The guide tube 704 has the first connector 724 a at the distal end 716and the second connector 724 b at the proximal end 714, for connectingto the two ends of the sling assembly 726. Two sleeve ends 734 a and 734b of the sling assembly 726 are interconnected with the distal end 716and the proximal end 714 of the guide tube 704, respectively. As inpreviously discussed guide tube embodiments where the guide tube doesnot connect to the handle, the guide tube 704 slidably interfits overthe shaft 702 without interconnection. The operator, using the shaft 702slidably interfitted in the guide tube 704, tunnels transvaginally tocreate the first tunnel 858 as described in connection with FIGS. 76Aand 76B, until the distal end 716 of the guide tube 704 and itsinterconnected sleeve end 734 a of the sleeve assembly 726 both emergefrom the abdominal skin 780.

Referring also to FIG. 79B, the operator then separates the sleeve end734 a from the distal end 716 of the guide tube 704, and withdraws thedelivery device 700 out of the vaginal wall 784 via the first tunnel858. The sleeve end 734 a of the sling assembly 726 remains outside theabdominal skin 780 with part of the sling assembly 726 residing insidethe first tunnel 858. The other sleeve end 734 b remains interconnectedto the proximal end 714 of the guide tube 704. The operator creates asecond tissue tunnel 890 from the vaginal wall 784 to the abdominal skin780 on the contralateral side of the urethra 786, similar to the firsttunnel 858, using the delivery device 700. After the distal end 716 ofthe guide tube 704 emerges from the abdominal skin 780, the operatorslides the shaft 702 out of the proximal opening 720 of the guide tube704, and withdraws the shaft 702 out of the vaginal wall 784 via thesecond tunnel 890. The operator grasps the distal end 716 of the guidetube 704 and pulls the guide tube 704 and its interconnected sleeve end734 b out of the abdominal skin 780 via the second tunnel 890. Once thesleeve end 734 b of the sling assembly 726 emerges out of the abdominalskin 780, the operator separates it from the proximal end 714 of theguide tube 704. The operator further adjusts the position and tension inthe sling assembly 726 before removing the sleeve member 730 from thesling 728 for implanting.

FIGS. 80A and 80B illustrate another transvaginal approach, whichemploys the delivery system of FIG. 70 or 71. As described previously,the sling assembly 726 is interconnected to the proximal end 746 a ofthe first guide tube 740 a and to the proximal end 746 b of the secondguide tube 740 b. The second guide tube 740 b slidably interfits overthe shaft 702 via proximal opening 750 (FIG. 70A), or via the side port754 b (FIG. 71). The first guide tube 740 a slidably interfits over thesecond guide tube 740 b via the proximal opening 744 (FIG. 70), or viathe side port 754 b (FIG. 71). The distal tip 707 of the shaft 702extends through a distal opening 742 of the first guide tube 740 a.

In use, the operator tunnels transvaginally to create the first tunnel858 as described in connection with FIGS. 76A and 76B, until the distalend 910 of the first guide tube 740 a emerges from the abdominal skin780. The operator then slides the second guide tube 740 b from insidethe first guide tube 740 a, and withdraws the second guide tube 740 bout of the vaginal wall 784 via the first tunnel 858. The distal end 910of the first guide tube 740 a is clamped outside the abdominal skin 780with the rest of the first guide tube 740 a remaining inside the firsttunnel 858. The end 930 a of the sling assembly 726 remainsinterconnected with the proximal end 746 a of the guide tube 740 a. Theoperator then creates a second tissue tunnel 940 from the vaginal wall784 to the abdominal skin 780 on the contralateral side of the urethra786, similar to the first tunnel 858, using the shaft 702 slidinglyinterfitted through the second guide tube 740 b. After a distal end 942of the second guide tube 740 b emerges from the abdominal skin 780, theoperator slides the shaft 702 out of the second guide tube 740 b, andwithdraws the shaft 702 out of the vaginal wall 784 via the secondtunnel 940. Subsequent to cystoscopy, the operator grasps both distalends 910 and 942 of the first and second guide tubes 740 a and 740 b,and pulls the two guide tubes 740 a and 740 b out of the abdominal skin780 via the first and second tunnels 858 and 940. Once the ends 930 aand 930 b of the sling assembly 726 emerge out of the abdominal skin780, the operator separates the ends 930 a and 930 b from the proximaltube ends 920 a and 920 b, respectively. The operator further adjuststhe position and tension in the sling assembly 726 before removing thesleeve member 730 from the body of the patient. Cystoscopy can beperformed while the guide tubes are in the tunnel before being pulledthrough.

FIGS. 81A and 81B depict an illustrative trans-obtruator approach usingthe delivery device 90 a of FIG. 17 or the delivery device 90 b of FIG.18. Other embodiments of delivery devices including those described hereor incorporated by reference can also be used for this approach. Takingthe delivery device 90 a as an example: as previously described, thedelivery device 90 a includes a shaft 92 a and a handle 93 a. The shaft92 a, at least in part, describes an arc of a substantial degree, forexample, no less than about 45, about 60, or about 90 degrees in variousembodiments. In one embodiment, the curve in the shaft 92 a forms a “C”configuration. In the alternative delivery device embodiment 90 bdescribed previously with respect to FIG. 18, the needle shaft 92 bdescribes the helical curve 94.

According to one exemplary embodiment of the trans-obturator approachusing the delivery device embodiment 90 a, a first incision 962 a ismade on the inside of the patient's thigh, for example, about 1 cmoutside the external margin of the labia majora. The operator insertsthe shaft 92 a, tip first, into the first incision 962 a on the thighand continues to penetrate a first obturator foramen 964 a. With arotating wrist motion, the shaft is guided along the posteriorischiopubic ramus to a first vaginal incision 966 a on the vaginal wall968. After a distal portion 958 of the shaft 92 a emerges out of thevaginal wall 968, the operator interconnects a first connector 960attached to the shaft distal end 958, with a second connector 798attached to the sleeve end 796 a. Alternatively, a guide tube such aspreviously described and having a connector attached to a distal end,can be slid over the shaft 952 before the incision, and the connector onthe guide tube can interconnect with the sleeve end 796 a. Then, theoperator withdraws the delivery device 90 a back out of the obturatorforamen 964 a, bringing the sleeve end 796 a of the sling assembly 788out of the first thigh incision 962 a.

Referring also to FIG. 81B, the operator repeats the above steps on thecontralateral side of the urethra 970 and threads or tunnels the othersleeve end 796 b through the other obturator foramen 964 b and out of asecond thigh incision 962 b. After proper adjustment of the position,the thigh incisions may be closed. In some embodiments the sling endsare anchored to the pelvic bones. However, in other embodiments, thesling ends remain unanchored. Alternatively, the operator can reversethe direction in the trans-obturator approach by starting from a vaginalincision and tunneling through the obturator foramen to the thighincision using the same embodiments described above.

V. Guide Member

According to one aspect of the invention, an implant, for example, asling assembly, can be equipped with guide members that facilitate thedelivery of the implant. The guide members can have a male insertivefeature or a female receptive feature. The guide member can be solid orhollow and may include laterally placed apertures. Various illustrativeguide member embodiments will now be discussed.

FIG. 82 depicts an illustrative sling assembly 1000. The sling assembly1000 includes a sling 1002, and two guide members 1004 a and 1004 b. Inthis embodiment, the guide members 1004 a and 1004 b are formed as solidrods, each having a first end (1006 a, 1006 b) and a second end (1008 a,1008 b). However, in other embodiments, the guide members 1004 a and1004 b may be hollow. In one embodiment, the second ends 1008 a and 1008b taper and are advantageous in performing insertive functions. In someconfigurations, the distal ends 1008 a and 1008 b terminate in conicaltips capable of tissue piercing functions. Alternatively, the guidemembers 1004 a and 1004 b have a substantially constant diameter. Theguide members 1004 a and 1004 b are shaped and sized to slidably movewithin an axial lumen 1009 of a guide tube 1010.

The illustrated guide members 1004 a and 1004 b are substantiallystraight and made from flexible materials that permit them to flex. Inone embodiment, the guide members 1004 a and 1004 b have enoughflexibility to negotiate a curve, for example, a curve in the lumen 1009of the guide tube 1010. According to another feature, the outer diameterof the guide members 1004 a and 1004 b are less than the inner diameterof the lumen 1009 of the guide tube 1010. In one embodiment, the firstends 1006 a and 1006 b of the guide members 1004 a and 1004 b areadjacent dilators 1020 a and 1020 b, respectively. In one embodiment,the guide members 1004 a and 1004 b are longer than the guide tube 1010.However, the guide members 1004 a and 1004 b may be of any suitablelength, including less than or equal to that of the guide tube 1010.

With continued reference to FIG. 82, the sling assembly 1000 may includea sleeve member 1022 that at least partly encloses the sling 1002. Thefirst end 1006 a of the guide member 1004 a secures to the sleeveassembly end 1021 a, for example, by heat bonding or other suitablemechanism. Similarly, the first end 1006 b of the guide member 1004 battaches to the sling assembly end 1021 b. In some embodiments, theguide members 1004 a and 1004 b interconnect with the sleeve assemblyends 1021 a and 1021 b through connectors such as those previouslydescribed and/or incorporated by reference in this application.

FIG. 83 depicts a sling assembly 1000 employing an alternativeembodiment of the guide members 1004 a and 1004 b. More particularly,the sling assembly 1000′ includes two guide member 1004 a′ and 1004 b′,which each have an axial lumen extending from a first end (1006 a′, 1006b′) a second end (1008 a′, 1008 b′). Optionally, the guide members 1004a′ and 1004 b′ each include one or more apertures 1024 a and 1024 b,respectively, which are in fluid communication with the axial lumen. Asdescribed previously in connection with FIGS. 10A, 10B and 11, theapertures 1024 a and 1024 b are advantageous in alerting the operator ofany perforation in an organ, such as the bladder, during the deliveryprocedure. The guide members 1004 a′ and 1004 b′ may or may not have adistal opening that is communicative with the axial lumen.

The guide members, which are interconnected with the sling assembly1022, can facilitate the delivery of the sling assembly to an anatomicalsite, whether in a suprapubic, prepubic, transvaginal, ortrans-obturator approach. In a preferred embodiment, the guide membersare used in conjunction with a guide tube. Referring to FIGS. 84A and84B, in one illustrative embodiment, the guide tube 1010 and 1010′ areinstalled between the vaginal wall 1034 and the abdominal skin 1032 oneither side of the urethra using any suitable transvaginal, suprapubicor prepubic.

Referring to FIG. 84C, the guide members 1004 a and 1004 b can then beinserted transvaginally through the guide tubes 1010 and 1010 I,respectively. The operator pulls the second ends 1008 a and 1008 b ofthe guide members 1004 a and 1004 b and the respective guide tubes 1010and 1010 I from the first and second tunnels 1030 and 1036 until thesleeve ends 1021 a and 1021 b emerge from the abdominal skin 1032. Theoperator then grasps the sleeve ends 1021 a and 1021 b and adjusts theposition and tension of the sleeve member 1022. Once positioned, thesleeve member 1022 is removed from the patient's body as previouslydescribed, leaving the sling 1002 in place.

FIG. 85 depicts an illustrative embodiment of a sling assembly 1050including guide members 1054 a and 1054 b having receptacle connectorsat their free ends 1058 a, 1058 b. Each of the guide members 1054 a and1054 b has a first end 1056 a, 1056 b) and a second, free end 1058 a,1058 b. A receptacle 1057 a, 1057 b extends from a terminal opening 1059a, 1059 b of the guide members 1054 a and 1054 b and terminates anywherealong the length of the guide members 1054 a and 1054 b. According toone feature, the guide members 1054 a and 1054 b have a tubularstructure with openings at both the first end (1056 a, 1056 b) and thesecond end (1058 a, 1058 b) that are in fluid communication with theaxial lumen (1057 a, 1057 b). In one embodiment, the free ends 1058 aand 1058 b of the guide members 1054 a and 1054 b taper axially inwardand are advantageous in performing tissue dilation. Alternatively, theguide members 1054 a and 1054 b have a substantially constant diameter.The receptacles 1057 a and 1057 b are shaped and sized to slidably fitover a distal end of a delivery shaft 1060. The shaft 1060 attaches at aproximal end 1065 to a handle 1064. Optionally, each of the guidemembers 1054 a and 1054 b may have one or more apertures 1066 a and 1066b, respectively, that are in fluid communication with the receptacles1057 a and 1057 b, respectively.

The illustrated guide members 1054 a and 1054 b may be made sufficientlyrigid to slide over the shaft 1060 against the pressure from surroundingtissue inside a tissue tunnel. For example, in one embodiment, the guidemembers 1054 a and 1054 b are made of stainless steel. In one feature,the first end (1056 a, 1056 b) of the guide members 1054 a and 1054 bare adjacent to an optional dilator (1070 a, 1070 b). In one embodiment,the guide members 1054 a and 1054 b are longer than the shaft 1060.However, the guide members 1054 a and 1054 b may be of any suitablelength, including less than or equal to that of the shaft 1060.

With continued reference to FIG. 85, the sling assembly 1050 may includea sleeve member 1072 that at least partly encloses the sling 1052. Theguide members 1054 a and 1054 b may be secured to the sleeve ends 1071 aand 1071 b, respectively, via the dilators 1070 a and 1070 b, forexample, by heat bonding or other suitable mechanism. Alternatively, theguide members 1054 a and 1054 b can be interconnected with the sleeveends 1071 a and 1071 b, respectively, via connectors such as thosedescribed previously.

The guide members 1054 a and 1054 b can facilitate the delivery of thesling assembly 1050 to an anatomical site, using a suprapubic, prepubic,transvaginal, trans-obturator, or any other approach. Referring to FIG.86A, in an illustrative embodiment of both the suprapubic and prepubicapproaches, a first tunnel 1080 between the abdominal skin 1082 and thevaginal wall 1084 is created by the insertion of the delivery device1062 from the abdominal side to the vaginal side as described above inother method embodiments. Once the operator has determined that thebladder has not been perforated, the operator slides the receptacle 1057a of the first guide member 1054 a onto the shaft 1060. The operatorproceeds to advance the first guide member 1054 a inside the firsttunnel 1080 onto the shaft 1060 until the second end 1058 a of the firstguide member 1054 a emerges from the patient's abdominal skin 1082. Theoptional tapering feature at the second end 1058 a of the first guidemember 1054 a is advantageous for the advancing step as the first guidemember 1054 a dilates the first tunnel 1080 to advance. If the firstguide member 1054 a includes the optional apertures 1066 a, fluidseeping through the apertures 1066 a will alert the operator toperforation of the bladder.

Referring also to FIG. 86B, the operator withdraws the shaft 1060,leaving the first guide member 1054 a in the first tunnel 1080 with thefirst end 1058 a outside the abdominal skin 1082. The operator then usesthe same shaft 1060 or a second shaft to create a second tunnel 1086 ina similar fashion on the contralateral side of the urethra 1088. Theoperator, repeating the steps with respect to the first guide member1054 a, advances the second guide member 1054 b inside the second tunnel1086 over the shaft 1060 until the second end 1058 b of the second guidemember 1054 b emerges from the abdominal skin 1082. The operator thenpulls the first and second guide members 1054 a and 1054 b from thepatient's tissues through the first 1080 and second 1086 tunnels,respectively, and out of the abdominal skin 1082, and completes thedelivery procedure as described above.

In an alternative embodiment, the shaft 1086 interfits tightly into thereceptacles 1057 a and 1057 b, and the operator withdraws the shaft 1086to withdraw the respective sleeve ends 1071 a and 1071 b through theabdominal incisions.

Referring now to FIG. 87A, in an illustrative embodiment of atransvaginal approach, the first tunnel 1080 between the vaginal wall1084 and the abdominal skin 1082 is created by the insertion of thedelivery device 1062 from the vaginal wall 1084 to get to the abdominalskin 1082 as described above in other method embodiments. The handle1064, which is reversibly associated with the shaft 1060, is taken offthe proximal end 1065 of the shaft 1060 (FIG. 85). The operator slidesthe first guide member 1054 a over the proximal end 1065 of the shaft1060 (FIG. 85), and advances the first guide member 1054 a in the firsttunnel 1080 until the second end 1058 a of the first guide member 1054 aemerges from the abdominal skin 1082.

Referring also to FIG. 87B, the operator then uses a second shaft 1090to create the second tunnel 1086 in a similar fashion on thecontralateral side of the urethra 1088. The operator, repeating thesteps with respect to the first guide member 1054 a, removes the handle1064 and slides the second guide member 1054 b over a proximal end ofthe second shaft 1090. The operator advances the second guide member1054 b inside the second tunnel 1086 over the second shaft 1090 untilthe distal end 1058 b of the second guide member 1054 b emerges from theabdominal skin 1082. The operator then pulls the first and second guidemembers 1054 a and 1054 b, with the first and second shafts 1060 and1090, out of the patient's body through the first 1080 and second 1086tunnels, respectively. After the first and second guide members 1054 aand 1054 b are out of the abdominal skin 1082, the operator completesthe delivery procedure as described above.

Variations, modifications, and other implementations of what isdescribed may be employed without departing from the spirit and thescope of the invention. More specifically, any of the method, system anddevice features described above or incorporated by reference may becombined with any other suitable method, system or device featuresdisclosed herein or incorporated by reference, and is within the scopeof the contemplated inventions.

1. A connector pair for attaching a medical implant to a deliverysystem, the connector pair comprising, a closed loop connector formedfrom a filament and located at an end of a medical implant, and a plugconnector located at a distal end of a shaft of a delivery system forinterfitting with the closed loop connector of the medical implant, theplug connector including an intermediate section having a diameter lessthan that of the distal end of the shaft and extending distally from thedistal end of the shaft, and a conical tip section, with a base locatedadjacent to the intermediate section and having a diameter larger thanthe diameter of the intermediate section, extending distally from theintermediate section.
 2. The connector pair of claim 1, wherein theclosed loop connector includes a helical loop formed in the filament,and sized to receive the conical tip of the plug connector and snap fitinto the intermediate section of the plug connector.
 3. The connectorpair of claim 2, wherein the helical loop is formed to expand over theconical tip of the plug connector and contract into the intermediatesection of the plug connector.
 4. The connector pair of claim 2, whereinthe conical tip mates with the helical loop from outside a perimeterdescribed by the closed loop connector to connect the medical implantand the shaft in an end-to-end configuration.
 5. The connector pair ofclaim 2, wherein the conical tip mates with the helical loop from insidea perimeter described by the closed loop connector.
 6. The connectorpair of claim 2, wherein the closed loop connector includes firstsection having a substantially triangular shape axially extending from abase at the end of the medical implant to an apex, and neck sectionhaving a width substantially equal to the width of the apex andextending axially from the apex to the helical loop, the helical loophaving a diameter larger than the width of the neck section.
 7. Theconnector pair of claim 2, wherein the implant is a sling assembly fortreating urinary incontinence. 8-22. (canceled)
 23. A connector pair forattaching a medical implant to a component of a delivery system, theconnector pair comprising, a receptacle connector located at an end of amedical implant and including a substantially cylindrical base and aplurality of axial projections located radially around the substantiallycylindrical base and defining an expandable channel, a plug connectorlocated at a distal end of a delivery system component and shaped forinterfitting with the expandable channel of the receptacle connector.24. The connector pair of claim 23, wherein each of the axialprojections include a protrusion extending radially into the expandablechannel and the plug connector includes an intermediate section having adiameter less than the distal end of the delivery system component forengaging the radially extending protrusions to interlock the plug andreceptacle connectors.
 25. The connector pair of claim 23, wherein theplug connector includes an end section extending distally from theintermediate section, and having a base with a diameter larger than thediameter of the intermediate section, the base being located adjacent tothe intermediate section.
 26. The connector pair of claim 25, whereinthe end section is conical shaped.
 27. The connector pair of claim 23,wherein the expandable channel has an initial diameter prior toexpansion sized to matingly seat the delivery system component.
 28. Theconnector pair of claim 24, wherein each of the axial projectionsinclude a protrusion extending radially outward from the receptacleconnector to form an expanded conical head.
 29. The connector pair ofclaim 23, wherein the medical implant is a sling assembly for treatingurinary incontinence.
 30. The connector pair of claim 23, wherein thedelivery system component is a shaft.
 31. The connector pair of claim23, wherein the delivery system component is an elongate tube.
 32. Aconnector pair for attaching a medical implant to a component of adelivery system, the connector pair comprising, a plug connector locatedat distal end of a delivery system component, and a receptacle connectorlocated at an end of a medical implant and including a base section forreceiving the plug connector and an outer annular collar forconcentrically sliding over the base section to compress the basesection and lock the plug connector in the receptacle connector.
 33. Theconnector of claim 32, wherein the medical implant is a sling assemblyfor treating urinary incontinence.
 34. The connector pair of claim 32,wherein the delivery system component is a shaft.
 35. The connector pairof claim 32, wherein the delivery system component is an elongate tube.36. The connector pair of claim 32, wherein the plug connector includesan intermediate section having a diameter less than that of the distalend of the delivery system component and extending distally from thedistal end of the delivery system component, and a tip section,extending distally from the intermediate section, and having a base witha diameter larger than the diameter of the intermediate section, thebase being located adjacent to the intermediate section, and the basesection of the receptacle connector includes a radially inwardlyprotruding collar for interfitting with the intermediate section of theplug connector in response to the outer annular collar compressing thebase section.
 37. A connector pair for attaching a medical implant to acomponent of a delivery system, the connector pair comprising, a plugconnector located at distal end of a delivery system component, andincluding an intermediate section having a diameter less than that ofthe distal end of the delivery system component and extending distallyfrom the distal end of the delivery system component, and a tip section,extending distally from the intermediate section, and having a base witha diameter larger than the diameter of the intermediate section, thebase being located adjacent to the intermediate section, and areceptacle connector located at an end of a medical implant andincluding a housing having a substantially tubular wall extendingbetween first and second ends of the housing, the substantially tubularwall including an axially extending slot through the wall, the axiallyextending slot being sized to interfit with the intermediate portion ofthe plug connector.
 38. The connector pair of claim 37, wherein theaxially extending slot extends from the first end to the second end ofthe housing.
 39. The connector pair of claim 37, wherein the axiallyextending slot includes a radially enlarged portion sized to accommodatethe tip section of the plug connector.
 40. A connector pair forattaching a medical implant to a component of a delivery system, theconnector pair comprising, a plug connector located at distal end of adelivery system component, and including an intermediate section havinga diameter less than that of the distal end of the delivery systemcomponent and extending distally from the distal end of the deliverysystem component, and a tip section, extending distally from theintermediate section, and having a base with a diameter larger than thediameter of the intermediate section, the base being located adjacent tothe intermediate section, and a receptacle connector having a housingwith first and second ends, the first end located at an end of a medicalimplant, and including an aperture extending radially through thehousing from a first side to a second side, a first channel extendingalong the first side of the housing from the aperture to the first end,and a second channel extending along the second side from the apertureto the second end, the tip section passing through the aperture from thefirst side to the second side and the plug and receptacle connectorsbeing rotated relative to each other to seat the intermediate section inthe first and second channels.
 41. A connector pair for attaching amedical implant to a component of a delivery system, the connector paircomprising, a threaded plug connector located at distal end of adelivery system component, and a threaded receptacle connector, locatedat an end of a medical implant, for threaded engagement with thethreaded plug connector.
 42. A connector pair for attaching a medicalimplant to a component of a delivery system, the connector paircomprising, a receptacle connector, located at an end of a medicalimplant and including, a substantially tubular housing having first andsecond ends, a wall extending there between, and a through apertureformed in the wall intermediate to the first and second ends, a springmember located adjacent to an outside portion of the housing wall andhaving a protuberance at a first end for projecting through the aperturein the housing wall, and a plug connector having a reduced diametersection for engaging with the protuberance at the first end of thespring through the through aperture in the housing wall during insertioninto the receptacle connector.
 43. A connector pair according to claim42 comprising a tubular collar concentrically interfitted around thereceptacle connector for sliding over the spring member to cause theprotuberance to engage with the reduced diameter section of the plugconnector.
 44. A connector pair for attaching a medical implant to adelivery system, the connector pair comprising, an open loop connectorformed from a filament and located at an end of a medical implant andincluding first and second hooked ends crossed relative to each other,and a plug connector located at a distal end of a delivery systemcomponent and including first and second notches for interfitting withthe first and second hooked ends respectively.